Matching articles for "COVID-19"
COVID-19 Update: New Novavax Vaccine Formulation for 2023-2024
The Medical Letter on Drugs and Therapeutics • November 13, 2023; (Issue 1689)
A new 2023-2024 formulation of the adjuvanted
protein subunit COVID-19 vaccine manufactured by
Novavax that was developed to more closely target
currently circulating SARS-CoV-2 variants has been
made...
A new 2023-2024 formulation of the adjuvanted
protein subunit COVID-19 vaccine manufactured by
Novavax that was developed to more closely target
currently circulating SARS-CoV-2 variants has been
made available in the US under an FDA Emergency Use Authorization (EUA) for use in persons ≥12
years old. The original formulation of the Novavax
vaccine is no longer authorized for use in the US.
In September, updated formulations of the mRNA
COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) were
licensed by the FDA for use in persons ≥12 years old
and made available under EUAs for use in persons
6 months to 11 years old.
Correction
The Medical Letter on Drugs and Therapeutics • November 13, 2023; (Issue 1689)
In our article in issue 1687 on the updated 2023-2024 COVID-19 vaccines
from Pfizer and Moderna (Med Lett Drugs Ther 2023; 65:161),
the doses and formulations of the Pfizer vaccine were incorrect. A
revised...
In our article in issue 1687 on the updated 2023-2024 COVID-19 vaccines
from Pfizer and Moderna (Med Lett Drugs Ther 2023; 65:161),
the doses and formulations of the Pfizer vaccine were incorrect. A
revised table has been posted in the online version of the article.
COVID-19 Update: New Pfizer and Moderna Vaccine Formulations for 2023-2024
The Medical Letter on Drugs and Therapeutics • October 16, 2023; (Issue 1687)
New 2023-2024 formulations of the mRNA COVID-19
vaccines manufactured by Pfizer/BioNTech
(Comirnaty) and...
New 2023-2024 formulations of the mRNA COVID-19
vaccines manufactured by Pfizer/BioNTech
(Comirnaty) and that more
closely target currently circulating variants have
been licensed by the FDA for use in persons ≥12 years
old and made available under FDA Emergency Use
Authorizations (EUAs) for use in persons 6 months
to 11 years old. The bivalent (original and Omicron
BA.4/5) formulations of the Pfizer and Moderna
vaccines are no longer authorized for use in the US.
Vaccination Recommendations for Updated 2023-2024 COVID-19 Vaccines (online only)
The Medical Letter on Drugs and Therapeutics • October 16, 2023; (Issue 1687)
...
View the Vaccination Recommendations for Updated 2023-2024 COVID-19 Vaccines
COVID-19 Update: An EUA for Vilobelimab (Gohibic) for COVID-19
The Medical Letter on Drugs and Therapeutics • May 29, 2023; (Issue 1677)
The investigational anti-complement component 5a
(C5a) antibody vilobelimab (Gohibic – InflaRx) has
been granted an FDA Emergency Use Authorization
(EUA) for IV treatment of hospitalized adults
with...
The investigational anti-complement component 5a
(C5a) antibody vilobelimab (Gohibic – InflaRx) has
been granted an FDA Emergency Use Authorization
(EUA) for IV treatment of hospitalized adults
with COVID-19 beginning within 48 hours after
invasive mechanical ventilation (IMV) or extracorporeal
membrane oxygenation (ECMO) is started.
Vilobelimab is the first anti-C5a antibody to become
available in the US.
COVID-19 Update: Metformin to Prevent Long Covid?
The Medical Letter on Drugs and Therapeutics • May 29, 2023; (Issue 1677)
Results from a double-blind trial suggest that off-label
use of the oral antihyperglycemic drug metformin
in patients with COVID-19 may decrease the risk
of post-acute sequelae of SARS-CoV-2...
Results from a double-blind trial suggest that off-label
use of the oral antihyperglycemic drug metformin
in patients with COVID-19 may decrease the risk
of post-acute sequelae of SARS-CoV-2 infection
("long COVID").
Vaccination Recommendations for Bivalent mRNA COVID-19 Vaccines (online only)
The Medical Letter on Drugs and Therapeutics • May 1, 2023; (Issue 1675)
...
View the Vaccination Recommendations for Bivalent mRNA COVID-19 Vaccines
Dosing Recommendations for Novavax and Johnson & Johnson COVID-19 Vaccines (online only)
The Medical Letter on Drugs and Therapeutics • May 1, 2023; (Issue 1675)
...
View the Dosing Recommendations for Novavax and Johnson & Johnson COVID-19 Vaccines
COVID-19 Update: Pfizer Bivalent Vaccine Booster Dose for Children 6 Months to 4 Years Old
The Medical Letter on Drugs and Therapeutics • April 17, 2023; (Issue 1674)
The FDA has expanded its Emergency Use
Authorization (EUA) for the COVID-19 vaccine
manufactured by Pfizer/BioNTech (Comirnaty) to
permit use of the bivalent formulation (containing
mRNA from the original...
The FDA has expanded its Emergency Use
Authorization (EUA) for the COVID-19 vaccine
manufactured by Pfizer/BioNTech (Comirnaty) to
permit use of the bivalent formulation (containing
mRNA from the original and BA.4/5 Omicron strains of
SARS-CoV-2) as a booster dose in children 6 months
to 4 years old who completed the primary series with
3 doses of the monovalent formulation ≥2 months
previously. The Pfizer bivalent vaccine had previously
been authorized for use as a booster dose in persons
≥5 years old and as a third primary dose in children 6
months to 4 years old. Booster doses of the Moderna bivalent COVID-19 vaccine (Spikevax) for children
6 months to 5 years old were authorized earlier.
Antiviral Drugs for COVID-19 in Vaccinated Outpatients
The Medical Letter on Drugs and Therapeutics • March 6, 2023; (Issue 1671)
Three products are currently available in the US for
treatment of high-risk,1 nonhospitalized adults with
mild to moderate COVID-19: oral ritonavir-boosted
nirmatrelvir (Paxlovid), IV remdesivir (Veklury),...
Three products are currently available in the US for
treatment of high-risk,1 nonhospitalized adults with
mild to moderate COVID-19: oral ritonavir-boosted
nirmatrelvir (Paxlovid), IV remdesivir (Veklury), and
oral molnupiravir (Lagevrio). Remdesivir is FDA-approved
for such use; nirmatrelvir/ritonavir and
molnupiravir are available under an FDA Emergency
Use Authorization. Because the pivotal clinical trials
of these products for outpatient use were conducted
in patients who were not vaccinated against
COVID-19, some clinicians have questioned whether
they can benefit vaccinated outpatients.
COVID-19 Update: Evusheld Unlikely to Neutralize XBB.1.5 Omicron Variant (online only)
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
The FDA has warned that the investigational long-acting
monoclonal antibodies tixagevimab and
cilgavimab (Evusheld – AstraZeneca) are unlikely
to neutralize the XBB.1.5 Omicron variant of SARS-CoV-2....
The FDA has warned that the investigational long-acting
monoclonal antibodies tixagevimab and
cilgavimab (Evusheld – AstraZeneca) are unlikely
to neutralize the XBB.1.5 Omicron variant of SARS-CoV-2. Evusheld is available under an Emergency Use
Authorization (EUA) for IM pre-exposure prophylaxis of
COVID-19 in persons ≥12 years old who weigh ≥40 kg
and have either a history of a severe adverse reaction
that prevents their vaccination against COVID-19 or
moderate or severe immune compromise.
COVID-19 Update: Tocilizumab (Actemra) FDA-Approved for Treatment of COVID-19 (online only)
The Medical Letter on Drugs and Therapeutics • January 9, 2023; (Issue 1667)
The interleukin-6 (IL-6) receptor antagonist
tocilizumab (Actemra – Genentech) has been
approved by the FDA for IV treatment of COVID-19
in hospitalized adults who are receiving a systemic
corticosteroid...
The interleukin-6 (IL-6) receptor antagonist
tocilizumab (Actemra – Genentech) has been
approved by the FDA for IV treatment of COVID-19
in hospitalized adults who are receiving a systemic
corticosteroid and require supplemental oxygen,
mechanical ventilation, or extracorporeal membrane
oxygenation (ECMO). Tocilizumab was previously
available for this indication under an Emergency
Use Authorization (EUA); it remains available under
an EUA for treatment of children 2-17 years old
who are hospitalized with COVID-19 and require
oxygen support.
COVID-19 Update: Bebtelovimab EUA Withdrawn (online only)
The Medical Letter on Drugs and Therapeutics • December 26, 2022; (Issue 1666)
The FDA has withdrawn its Emergency Use
Authorization (EUA) of the investigational anti-SARS-CoV-2 monoclonal antibody bebtelovimab
(LY-CoV1404 – Lilly) for treatment of COVID-19.
Bebtelovimab is not...
The FDA has withdrawn its Emergency Use
Authorization (EUA) of the investigational anti-SARS-CoV-2 monoclonal antibody bebtelovimab
(LY-CoV1404 – Lilly) for treatment of COVID-19.
Bebtelovimab is not expected to retain activity
against the Omicron variants BQ.1 and BQ.1.1, which
currently cause the majority of COVID-19 cases in all
regions of the US.
An EUA for Anakinra (Kineret) for COVID-19 (online only)
The Medical Letter on Drugs and Therapeutics • December 12, 2022; (Issue 1665)
The recombinant interleukin-1 (IL-1) receptor
antagonist anakinra (Kineret – Sobi) has been
granted an FDA Emergency Use Authorization
(EUA) for treatment of hospitalized adults with
confirmed COVID-19...
The recombinant interleukin-1 (IL-1) receptor
antagonist anakinra (Kineret – Sobi) has been
granted an FDA Emergency Use Authorization
(EUA) for treatment of hospitalized adults with
confirmed COVID-19 pneumonia who require low- or
high-flow supplemental oxygen, are at risk of
progressing to severe respiratory failure, and are
likely to have elevated plasma levels of soluble
urokinase plasminogen activator receptor (suPAR).
Anakinra has been available in the US for years; it
is FDA-approved for multiple indications, including
rheumatoid arthritis. Assays for suPAR are not
commercially available in the US.
COVID-19 Update: Bivalent Pfizer and Moderna Vaccines Authorized for Children ≥6 Months Old (Online Only)
The Medical Letter on Drugs and Therapeutics • December 12, 2022; (Issue 1665)
The FDA has expanded its Emergency Use
Authorizations (EUAs) for the COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to permit use of the bivalent
formulations of these...
The FDA has expanded its Emergency Use
Authorizations (EUAs) for the COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to permit use of the bivalent
formulations of these products (containing mRNA
from the original and BA.4/5 Omicron strains of
SARS-CoV-2) in children as young as 6 months.
The bivalent Pfizer vaccine is authorized for use as
the final dose of a 3-dose primary series in children
6 months to 4 years old. The bivalent Moderna
vaccine is authorized for use as a booster dose in
children 6 months to 5 years old who completed
a primary series with the monovalent Moderna
vaccine.1 Bivalent vaccines had previously been
authorized for use as a booster dose in persons
≥5 years old (Pfizer) or ≥6 years old (Moderna).
COVID-19 Update: Resistance to Bebtelovimab (online only)
The Medical Letter on Drugs and Therapeutics • November 28, 2022; (Issue 1664)
The FDA has warned that the investigational anti-SARS-CoV-2 monoclonal antibody bebtelovimab
is not expected to retain activity against the
Omicron variants BQ. and BQ.1.1.1 Bebtelovimab
(LY-CoV1404 –...
The FDA has warned that the investigational anti-SARS-CoV-2 monoclonal antibody bebtelovimab
is not expected to retain activity against the
Omicron variants BQ. and BQ.1.1.1 Bebtelovimab
(LY-CoV1404 – Lilly) is available under an FDA
Emergency Use Authorization (EUA) for IV treatment
of mild to moderate COVID-19 in high-risk patients
≥12 years old who weigh ≥40 kg for whom alternative
treatment options are unavailable or inappropriate.
The drug remains authorized for use in all regions
of the US.
COVID-19 Update: Novavax Vaccine Authorized for Booster Immunization (online only)
The Medical Letter on Drugs and Therapeutics • October 31, 2022; (Issue 1662)
The FDA has expanded its Emergency Use
Authorization for the adjuvanted protein subunit
COVID-19 vaccine manufactured by Novavax to
include its use as a first booster dose in adults
who completed a primary...
The FDA has expanded its Emergency Use
Authorization for the adjuvanted protein subunit
COVID-19 vaccine manufactured by Novavax to
include its use as a first booster dose in adults
who completed a primary series with any COVID-19
vaccine ≥6 months previously and are unable or
unwilling to receive a booster dose of a bivalent mRNA
vaccine. The Novavax vaccine is not authorized for
use in persons who have received a booster dose of
any other COVID-19 vaccine.
COVID Update: Bivalent Vaccine Booster Doses Authorized for Children ≥5 Years Old (online only)
The Medical Letter on Drugs and Therapeutics • October 17, 2022; (Issue 1661)
The FDA has expanded its Emergency Use
Authorizations (EUAs) for the COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to permit use of the bivalent
formulations of these...
The FDA has expanded its Emergency Use
Authorizations (EUAs) for the COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to permit use of the bivalent
formulations of these products (containing mRNA
from the original and BA.4/5 Omicron strains of
SARS-CoV-2) as a booster dose in children as young
as 5 years old (Pfizer) or 6 years old (Moderna).
The bivalent Pfizer vaccine had previously been
authorized for use in persons ≥12 years old and the
bivalent Moderna vaccine in persons ≥18 years old. Bivalent vaccines are not authorized for primary
immunization against COVID-19. The monovalent
Pfizer and Moderna COVID-19 vaccines are no longer
authorized for use as booster doses in any age group.
COVID-19 Update: Bivalent Pfizer and Moderna COVID-19 Vaccines for Booster Immunization
The Medical Letter on Drugs and Therapeutics • October 3, 2022; (Issue 1660)
The FDA has amended its Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) to permit use of bivalent
formulations of the...
The FDA has amended its Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) to permit use of bivalent
formulations of the products as a single booster dose
in persons ≥12 years old (Pfizer) or ≥18 years old
(Moderna) whose most recent COVID-19 vaccine dose
was a monovalent product given ≥2 months previously
as a booster or for completion of a primary series. The
bivalent formulations are not authorized for primary
immunization. Monovalent Pfizer and Moderna
COVID-19 vaccines are no longer authorized for use as
booster doses in persons ≥12 years old.
COVID-19 Update: Novavax Vaccine Authorized for Adolescents 12-17 Years Old (online only)
The Medical Letter on Drugs and Therapeutics • October 3, 2022; (Issue 1660)
The FDA has expanded its Emergency Use
Authorization for the adjuvanted protein subunit
COVID-19 vaccine manufactured by Novavax to
include use of the vaccine as a two-dose primary
series in adolescents...
The FDA has expanded its Emergency Use
Authorization for the adjuvanted protein subunit
COVID-19 vaccine manufactured by Novavax to
include use of the vaccine as a two-dose primary
series in adolescents 12-17 years old. The vaccine
was authorized for primary immunization of adults in
July 2022.
COVID-19 Update: FDA Authorizes Novavax COVID-19 Vaccine
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has issued an Emergency Use Authorization
(EUA) for an adjuvanted protein subunit COVID-19
vaccine manufactured by Novavax. The vaccine
is indicated for use as a two-dose primary series
to prevent...
The FDA has issued an Emergency Use Authorization
(EUA) for an adjuvanted protein subunit COVID-19
vaccine manufactured by Novavax. The vaccine
is indicated for use as a two-dose primary series
to prevent COVID-19 in adults; it is not authorized
for use in children or as a booster dose. Three
other COVID-19 vaccines are available in the US for
primary immunization of adults; the mRNA vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) are FDA-licensed for this indication,
and the adenovirus-based vaccine manufactured
by Johnson & Johnson (Janssen) is available under an
EUA for use in adults who are unable or unwilling to
receive another COVID-19 vaccine.
COVID-19 Update: Dosing Interval for Tixagevimab/Cilgavimab (Evusheld) (online only)
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has amended its Emergency Use
Authorization (EUA) for the investigational long-acting
monoclonal antibodies tixagevimab and
cilgavimab (Evusheld – AstraZeneca) to recommend
repeat dosing every 6...
The FDA has amended its Emergency Use
Authorization (EUA) for the investigational long-acting
monoclonal antibodies tixagevimab and
cilgavimab (Evusheld – AstraZeneca) to recommend
repeat dosing every 6 months in patients who require
ongoing protection against COVID-19. Evusheld
is authorized for IM pre-exposure prophylaxis of
COVID-19 in persons ≥12 years old who weigh ≥40 kg
and have either a history of a severe adverse reaction
that prevents their vaccination against COVID-19 or
moderate or severe immune compromise
COVID-19 Update: Prescription of Paxlovid by Pharmacists (online only)
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed...
The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed pharmacists in certain situations. Paxlovid is authorized for oral treatment of mild to moderate COVID-19 in high-risk outpatients ≥12 years old who weigh at least 40 kg. NIH guidelines list it as the treatment of choice for COVID-19 in high-risk adult outpatients.
Drugs for Treatment and Prevention of Venous Thromboembolism
The Medical Letter on Drugs and Therapeutics • July 25, 2022; (Issue 1655)
Anticoagulants are the drugs of choice for treatment
and prevention of deep venous thrombosis (DVT) and
pulmonary embolism (PE), collectively referred to as
venous thromboembolism (VTE). US guidelines...
Anticoagulants are the drugs of choice for treatment
and prevention of deep venous thrombosis (DVT) and
pulmonary embolism (PE), collectively referred to as
venous thromboembolism (VTE). US guidelines for
treatment of VTE were updated in 2020 and 2021.
COVID-19 Update: Pfizer/BioNTech and Moderna Vaccines Authorized for Children ≥6 Months Old
The Medical Letter on Drugs and Therapeutics • July 11, 2022; (Issue 1654)
The FDA has expanded its Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to allow for their use in children
as young as...
The FDA has expanded its Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to allow for their use in children
as young as 6 months old. The Pfizer vaccine was
previously authorized for use in persons ≥5 years old,
and the Moderna vaccine was authorized for use in
adults ≥18 years old.
COVID-19 Update: Hypersensitivity Reactions with Tixagevimab/Cilgavimab (Evusheld)
The Medical Letter on Drugs and Therapeutics • July 11, 2022; (Issue 1654)
The labeling for the investigational, long-acting,
prophylactic anti-SARS-CoV-2 monoclonal antibodies
tixagevimab and cilgavimab (Evusheld; available under
an FDA Emergency Use Authorization) now...
The labeling for the investigational, long-acting,
prophylactic anti-SARS-CoV-2 monoclonal antibodies
tixagevimab and cilgavimab (Evusheld; available under
an FDA Emergency Use Authorization) now includes
warnings about a risk of serious hypersensitivity
reactions, including anaphylaxis, with use of the
drugs, particularly in patients who have experienced a
hypersensitivity reaction to a COVID-19 vaccine.
COVID-19 Update: NIH Recommends Against Ivermectin
The Medical Letter on Drugs and Therapeutics • June 13, 2022; (Issue 1652)
On April 29, the NIH recommended against use of the antiparasitic drug ivermectin for treatment of COVID-19 outside of a clinical trial. The recommendation was made because recent randomized, placebo-controlled...
On April 29, the NIH recommended against use of the antiparasitic drug ivermectin for treatment of COVID-19 outside of a clinical trial. The recommendation was made because recent randomized, placebo-controlled trials of ivermectin have produced negative results and because alternative drugs that have been shown to be effective for treatment of COVID-19 are available.
COVID-19 Update: Baricitinib (Olumiant) FDA-Approved for Treatment of COVID-19 (online only)
The Medical Letter on Drugs and Therapeutics • June 13, 2022; (Issue 1652)
The FDA has approved the oral Janus kinase (JAK) inhibitor baricitinib (Olumiant) for treatment of COVID-19 in hospitalized adults who require supplemental oxygen, mechanical ventilation, or extracorporeal...
The FDA has approved the oral Janus kinase (JAK) inhibitor baricitinib (Olumiant) for treatment of COVID-19 in hospitalized adults who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib was previously available for this indication under an Emergency Use Authorization (EUA); it remains available under an EUA for use in children 2-17 years old hospitalized with COVID-19 who require oxygen support.
COVID-19 Update: Booster Dose of the Pfizer Vaccine for Children 5-11 Years Old
The Medical Letter on Drugs and Therapeutics • June 13, 2022; (Issue 1652)
The FDA has expanded its Emergency Use Authorization for the mRNA COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to include administration of a booster dose in children 5-11 years old who...
The FDA has expanded its Emergency Use Authorization for the mRNA COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to include administration of a booster dose in children 5-11 years old who completed a primary series of the Pfizer vaccine ≥5 months previously.
COVID-19 Update: FDA Narrows EUA for the Johnson & Johnson Vaccine
The Medical Letter on Drugs and Therapeutics • June 13, 2022; (Issue 1652)
The FDA has restricted its Emergency Use Authorization for the adenovirus-based COVID-19 vaccine manufactured by Johnson & Johnson (Janssen) to adults who are unable or unwilling to receive another COVID-19...
The FDA has restricted its Emergency Use Authorization for the adenovirus-based COVID-19 vaccine manufactured by Johnson & Johnson (Janssen) to adults who are unable or unwilling to receive another COVID-19 vaccine. The mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) are preferred for all persons without a contraindication.
COVID-19 Update: Remdesivir (Veklury) FDA-Approved for Children <12 Years Old (online only)
The Medical Letter on Drugs and Therapeutics • June 13, 2022; (Issue 1652)
IV antiviral drug remdesivir (Veklury) has now been FDA-approved for treatment of COVID-19 in patients ≥28 days old who weigh ≥3 kg and are either hospitalized or at high risk for progression to severe...
IV antiviral drug remdesivir (Veklury) has now been FDA-approved for treatment of COVID-19 in patients ≥28 days old who weigh ≥3 kg and are either hospitalized or at high risk for progression to severe disease. Remdesivir was already FDA-approved for these indications in patients ≥12 years old who weigh ≥40 kg; it was available under an Emergency Use Authorization (EUA) for younger or lighter patients. Remdesivir is the first drug to be FDA-approved for treatment of COVID-19 in children <12 years old.
COVID-19 Updates
The Medical Letter on Drugs and Therapeutics • April 18, 2022; (Issue 1648)
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer-BioNTech (Comirnaty) and
Moderna (Spikevax) to allow for their use as a second
booster dose...
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer-BioNTech (Comirnaty) and
Moderna (Spikevax) to allow for their use as a second
booster dose ≥4 months after a first booster dose in
adults ≥50 years old and in persons aged ≥12 years
(Pfizer) or ≥18 years (Moderna) who have undergone
solid organ transplantation or have a condition that
compromises the immune system to a similar extent.
An EUA for Bebtelovimab for Treatment of COVID-19
The Medical Letter on Drugs and Therapeutics • March 21, 2022; (Issue 1646)
The investigational monoclonal antibody
bebtelovimab (LY-CoV1404 – Lilly) has been granted
an FDA Emergency Use Authorization (EUA) for IV
treatment of mild to moderate COVID-19 in patients
≥12 years...
The investigational monoclonal antibody
bebtelovimab (LY-CoV1404 – Lilly) has been granted
an FDA Emergency Use Authorization (EUA) for IV
treatment of mild to moderate COVID-19 in patients
≥12 years old who weigh ≥40 kg and are at high
risk of progressing to severe disease, including
hospitalization and death, and for whom alternative
treatment options are unavailable or inappropriate.
Bebtelovimab is active against the Omicron variant of
SARS-CoV-2; sotrovimab (VIR-7831) is the only other
monoclonal antibody currently available for treatment
of COVID-19 that is active against Omicron.
COVID-19 Updates
The Medical Letter on Drugs and Therapeutics • March 21, 2022; (Issue 1646)
The CDC has issued new guidance allowing for
an interval of up to 8 weeks between the first and
second primary doses of an mRNA COVID-19 vaccine
in certain patients 12-64 years old.1 Product...
The CDC has issued new guidance allowing for
an interval of up to 8 weeks between the first and
second primary doses of an mRNA COVID-19 vaccine
in certain patients 12-64 years old.1 Product labeling
currently recommends a 3-week interval between the
first two doses of the Pfizer/BioNTech mRNA vaccine
(Comirnaty) and a 4-week interval between the first
two doses of the Moderna mRNA vaccine (Spikevax).
The new guidance is based on data suggesting that
a longer interval can decrease the risk of myocarditis
and may improve vaccine efficacy.
COVID-19 Updates
The Medical Letter on Drugs and Therapeutics • February 21, 2022; (Issue 1644)
The IV antiviral drug remdesivir (Veklury – Gilead)
has been available for treatment of COVID-19 in
hospitalized patients since 2020. Now, the FDA has
approved remdesivir for treatment of mild to...
The IV antiviral drug remdesivir (Veklury – Gilead)
has been available for treatment of COVID-19 in
hospitalized patients since 2020. Now, the FDA has
approved remdesivir for treatment of mild to moderate
COVID-19 in outpatients ≥12 years old who weigh
≥40 kg and are at high risk for progression to severe
disease, including hospitalization or death; they
also issued an Emergency Use Authorization (EUA)
allowing its use in any other high-risk outpatient who
weighs ≥3.5 kg.
Treatment of COVID-19 in High-Risk Outpatients (online only)
The Medical Letter on Drugs and Therapeutics • January 28, 2022; (Issue 1643)
...
View the Treatment of COVID-19 in High-Risk Outpatients Chart
Paxlovid for Treatment of COVID-19
The Medical Letter on Drugs and Therapeutics • January 24, 2022; (Issue 1642)
On December 22, 2021, the FDA issued an Emergency
Use Authorization (EUA) for the investigational
antiviral drug nirmatrelvir copackaged with the HIV-1
protease inhibitor ritonavir (Paxlovid – Pfizer)...
On December 22, 2021, the FDA issued an Emergency
Use Authorization (EUA) for the investigational
antiviral drug nirmatrelvir copackaged with the HIV-1
protease inhibitor ritonavir (Paxlovid – Pfizer) for
oral treatment of mild to moderate COVID-19 in
outpatients ≥12 years old who weigh at least 40 kg
and are at high risk of progressing to severe disease,
including hospitalization or death. Paxlovid was the
first oral antiviral drug to be authorized in the US for
treatment of COVID-19; Merck's oral antiviral drug
molnupiravir was granted an EUA for treatment of
COVID-19 on December 23, 2021. The
IV antiviral drug remdesivir (Veklury) was approved
by the FDA in 2020 for treatment of COVID-19 in
hospitalized patients.
Molnupiravir - An Oral Antiviral Drug for COVID-19
The Medical Letter on Drugs and Therapeutics • January 24, 2022; (Issue 1642)
The investigational oral antiviral drug molnupiravir
(Merck/Ridgeback Biotherapeutics) was granted an
FDA Emergency Use Authorization (EUA) on December
23, 2021 for treatment of mild to moderate COVID-19
in...
The investigational oral antiviral drug molnupiravir
(Merck/Ridgeback Biotherapeutics) was granted an
FDA Emergency Use Authorization (EUA) on December
23, 2021 for treatment of mild to moderate COVID-19
in outpatients ≥18 years old who are at high risk of
progressing to severe disease, including hospitalization
or death (see Table 1), and for whom alternative treatment options are
not available or clinically appropriate. Paxlovid (Pfizer),
nirmatrelvir copackaged with ritonavir, was granted
an EUA on December 22, 2021. The IV antiviral drug
remdesivir (Veklury) was approved by the FDA in 2020
for treatment of COVID-19 in hospitalized patients.
COVID-19 Updates
The Medical Letter on Drugs and Therapeutics • January 24, 2022; (Issue 1642)
On January 3, the FDA amended its Emergency
Use Authorization (EUA) for the Pfizer-BioNTech
COVID-19 vaccine (Comirnaty) to incorporate the
following changes. The anti-SARS-CoV-2 antibody...
On January 3, the FDA amended its Emergency
Use Authorization (EUA) for the Pfizer-BioNTech
COVID-19 vaccine (Comirnaty) to incorporate the
following changes. The anti-SARS-CoV-2 antibody combinations
casirivimab plus imdevimab (REGEN-COV) and
bamlanivimab plus etesevimab are not active
against the Omicron variant of SARS-CoV-2.
Tixagevimab and Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis of COVID-19
The Medical Letter on Drugs and Therapeutics • January 10, 2022; (Issue 1641)
The FDA has issued an Emergency Use Authorization
(EUA) for the investigational long-acting monoclonal
antibodies tixagevimab and cilgavimab (Evusheld –
AstraZeneca) to be administered concomitantly by...
The FDA has issued an Emergency Use Authorization
(EUA) for the investigational long-acting monoclonal
antibodies tixagevimab and cilgavimab (Evusheld –
AstraZeneca) to be administered concomitantly by IM
injection for pre-exposure prophylaxis of COVID-19 in
persons ≥12 years old who weigh ≥40 kg and have
either a history of severe allergy that prevents their
vaccination against COVID-19 or moderate or severe
immune compromise (see Table 1). They are the first
drugs to be authorized by the FDA for this indication.
Two other pairs of antibodies, bamlanivimab plus
etesevimab (Lilly) and casirivimab plus imdevimab
(REGEN-COV), are authorized for post-exposure
prophylaxis of COVID-19.
In Brief: Booster Doses of mRNA-Based COVID-19 Vaccines for All Adults
The Medical Letter on Drugs and Therapeutics • December 27, 2021; (Issue 1640)
On November 19, the FDA expanded the Emergency Use
Authorizations (EUAs) for the mRNA-based COVID-19
vaccines manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) to include administration
of...
On November 19, the FDA expanded the Emergency Use
Authorizations (EUAs) for the mRNA-based COVID-19
vaccines manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) to include administration
of a booster dose for all adults ≥18 years old after
primary immunization with either the same COVID-19
vaccine or a different one. Booster doses of these
vaccines were previously authorized only for select
populations (age ≥65 years or persons at high risk for
severe COVID-19). The EUA for the adenovirus-based
vaccine manufactured by Johnson & Johnson was
amended in October 2021 to include administration of
a booster dose for all adults ≥18 years old after primary
immunization with the Johnson & Johnson vaccine.
In Brief: Pfizer/BioNTech COVID-19 Vaccine Authorized for Children 5-11 Years Old
The Medical Letter on Drugs and Therapeutics • November 29, 2021; (Issue 1638)
The FDA has issued an Emergency Use Authorization
(EUA) for a lower-strength (10 mcg/0.2 mL) formulation
of the mRNA-based COVID-19 vaccine
manufactured by Pfizer/BioNTech (Comirnaty) for use
in children...
The FDA has issued an Emergency Use Authorization
(EUA) for a lower-strength (10 mcg/0.2 mL) formulation
of the mRNA-based COVID-19 vaccine
manufactured by Pfizer/BioNTech (Comirnaty) for use
in children 5-11 years old. The original formulation
of (Comirnaty) (30 mcg/0.3 mL) is FDA-licensed for
use in persons ≥16 years old and available under an
EUA for use in adolescents 12-15 years old.
Booster Doses of COVID-19 Vaccines
The Medical Letter on Drugs and Therapeutics • November 29, 2021; (Issue 1638)
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA-based COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) and the adenovirus-based...
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA-based COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) and the adenovirus-based vaccine
manufactured by Johnson & Johnson/Janssen to
include administration of a booster dose in select
populations after primary immunization with either the
same COVID-19 vaccine or a different one.
Drugs for Rheumatoid Arthritis
The Medical Letter on Drugs and Therapeutics • November 15, 2021; (Issue 1637)
Rheumatoid arthritis (RA) is prevalent in 0.5% of
adults in the US; it is about 2.5 times more common
in women than in men. Guidelines for treatment
of RA from the American College of Rheumatology
were...
Rheumatoid arthritis (RA) is prevalent in 0.5% of
adults in the US; it is about 2.5 times more common
in women than in men. Guidelines for treatment
of RA from the American College of Rheumatology
were recently updated. The goal of treatment is to
minimize disease activity and prevent irreversible
joint damage.
Booster Dose of the Pfizer/BioNTech COVID-19 Vaccine (Comirnaty)
The Medical Letter on Drugs and Therapeutics • October 18, 2021; (Issue 1635)
On September 22, on the advice of its Vaccines and
Related Biologic Products Advisory Committee, the
FDA expanded the Emergency Use Authorization
(EUA) for the Pfizer/BioNTech mRNA-based COVID-19
vaccine...
On September 22, on the advice of its Vaccines and
Related Biologic Products Advisory Committee, the
FDA expanded the Emergency Use Authorization
(EUA) for the Pfizer/BioNTech mRNA-based COVID-19
vaccine (Comirnaty) to include administration of a
booster dose ≥6 months after a 2-dose primary series
in adults who are ≥65 years old or at high risk for severe
COVID-19 because of an underlying medical condition
or frequent institutional or occupational exposure
to SARS-CoV-2 (see Table 1). The FDA Advisory
Committee recommended against authorization of a
booster dose of Comirnaty for all persons ≥16 years
old, citing a lack of adequate data.
Bamlanivimab and Etesevimab for Post-Exposure Prophylaxis of COVID-19
The Medical Letter on Drugs and Therapeutics • October 18, 2021; (Issue 1635)
In February 2021, the FDA issued an Emergency Use
Authorization (EUA) for the investigational monoclonal
antibodies bamlanivimab and etesevimab (Lilly) for
use together to treat mild to moderate COVID-19
in...
In February 2021, the FDA issued an Emergency Use
Authorization (EUA) for the investigational monoclonal
antibodies bamlanivimab and etesevimab (Lilly) for
use together to treat mild to moderate COVID-19
in persons ≥12 years old who weigh ≥40 kg and
are at high risk of progression to severe disease or
hospitalization. The FDA has now expanded this
EUA to allow use of the antibodies together for post-exposure
prophylaxis of COVID-19 in such persons
if they are not fully vaccinated against COVID-19 or
are unlikely to have an adequate immune response
to full vaccination and have been in close contact
with a SARS-CoV-2-infected individual or are likely
to be exposed to SARS-CoV-2 in the setting of an
institutional outbreak (see Table 1). Bamlanivimab
plus etesevimab is the second monoclonal antibody
combination to receive an EUA for post-exposure
prophylaxis of COVID-19; casirivimab plus imdevimab
(REGEN-COV) was authorized earlier.
In Brief: Third Dose of mRNA-based COVID-19 Vaccines for Immunocompromised Persons
The Medical Letter on Drugs and Therapeutics • September 20, 2021; (Issue 1633)
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA-based COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to include administration of a third
dose...
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA-based COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to include administration of a third
dose in persons ≥12 years old (Pfizer/BioNTech) or ≥18
years old (Moderna) who have undergone solid organ
transplantation or have a condition that compromises
the immune system to a similar extent (see Table 1).
Casirivimab and Imdevimab (REGEN-COV) for Post-Exposure Prophylaxis of COVID-19
The Medical Letter on Drugs and Therapeutics • August 23, 2021; (Issue 1631)
The investigational monoclonal antibodies casirivimab
and imdevimab (REGEN-COV – Regeneron) have
been available in the US under an Emergency Use
Authorization (EUA) since late 2020 for use together
to...
The investigational monoclonal antibodies casirivimab
and imdevimab (REGEN-COV – Regeneron) have
been available in the US under an Emergency Use
Authorization (EUA) since late 2020 for use together
to treat mild to moderate COVID-19 in persons ≥12
years old who weigh ≥40 kg and are at high risk of
progression to severe disease or hospitalization. The
FDA has now expanded this EUA to allow use of the
antibodies together for post-exposure prophylaxis
of COVID-19 in such persons, if they are not fully
vaccinated against COVID-19 or are unlikely to have
an adequate immune response to full vaccination
and have been in close contact with a SARS-CoV-2-infected individual or are likely to be exposed to SARS-CoV-2 in the setting of an institutional outbreak (see
Table 1). Casirivimab and imdevimab are the first
drugs to receive an EUA for post-exposure prophylaxis
of COVID-19.
Ponesimod (Ponvory) for Multiple Sclerosis
The Medical Letter on Drugs and Therapeutics • August 9, 2021; (Issue 1630)
The FDA has approved ponesimod (Ponvory –
Janssen), a sphingosine 1-phosphate (S1P) receptor
modulator, for treatment of adults with relapsing forms
of multiple sclerosis (MS), including clinically...
The FDA has approved ponesimod (Ponvory –
Janssen), a sphingosine 1-phosphate (S1P) receptor
modulator, for treatment of adults with relapsing forms
of multiple sclerosis (MS), including clinically isolated
syndrome (initial neurological episode), relapsing-remitting
disease, and active secondary progressive
MS (SPMS). Ponesimod is the fourth oral S1P receptor
modulator to be approved in the US for once-daily
treatment of relapsing forms of MS; ozanimod
(Zeposia) and siponimod (Mayzent) are also approved
for use in adults, and fingolimod (Gilenya) is indicated
for use in patients ≥10 years old.
In Brief: Guillain-Barré Syndrome with the Johnson & Johnson COVID-19 Vaccine
The Medical Letter on Drugs and Therapeutics • August 9, 2021; (Issue 1630)
On July 12, 2021, the FDA added a warning to the
Fact Sheet for the Johnson & Johnson (Janssen)
adenovirus-based COVID-19 vaccine about an
increased risk of Guillain-Barré syndrome (GBS)
following...
On July 12, 2021, the FDA added a warning to the
Fact Sheet for the Johnson & Johnson (Janssen)
adenovirus-based COVID-19 vaccine about an
increased risk of Guillain-Barré syndrome (GBS)
following administration of the product.
An EUA for Tocilizumab (Actemra) for COVID-19
The Medical Letter on Drugs and Therapeutics • July 26, 2021; (Issue 1629)
The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has received an
Emergency Use Authorization (EUA) from the FDA for IV treatment of COVID-19 in hospitalized patients ≥2
years...
The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has received an
Emergency Use Authorization (EUA) from the FDA for IV treatment of COVID-19 in hospitalized patients ≥2
years old who are receiving a systemic corticosteroid and require supplemental oxygen, mechanical
ventilation, or extracorporeal membrane oxygenation (ECMO). Tocilizumab has been approved by the FDA
for various indications, including rheumatoid arthritis and juvenile idiopathic arthritis.
An EUA for Sotrovimab for Treatment of COVID-19
The Medical Letter on Drugs and Therapeutics • June 28, 2021; (Issue 1627)
The investigational monoclonal antibody sotrovimab
(VIR-7831; GSK/Vir Biotechnology) has been granted
an FDA Emergency Use Authorization (EUA) for
treatment of mild to moderate COVID-19 in patients
≥12...
The investigational monoclonal antibody sotrovimab
(VIR-7831; GSK/Vir Biotechnology) has been granted
an FDA Emergency Use Authorization (EUA) for
treatment of mild to moderate COVID-19 in patients
≥12 years old who weigh ≥40 kg and are at high
risk of progressing to severe disease, including
hospitalization and death.1 Two other monoclonal
antibody regimens are authorized for the same
indication: casirivimab (REGN10933) and imdevimab
(REGN10987) administered together, and bamlanivimab (LY-CoV555) and etesevimab (LYCoV016)
administered together.
The FDA revoked its EUA
for bamlanivimab alone in April 2021 because an
increasing percentage of COVID-19 cases in the US
are being caused by SARS-CoV-2 variants that are
resistant to monotherapy with the drug.
In Brief: Pfizer/BioNTech COVID-19 Vaccine Authorized for Adolescents 12-15 Years Old
The Medical Letter on Drugs and Therapeutics • May 31, 2021; (Issue 1625)
On May 10, 2021, the FDA expanded its Emergency
Use Authorization (EUA) for the Pfizer/BioNTech
mRNA-based COVID-19 vaccine to include adolescents
12-15 years old.1The vaccine has been
authorized for use in...
On May 10, 2021, the FDA expanded its Emergency
Use Authorization (EUA) for the Pfizer/BioNTech
mRNA-based COVID-19 vaccine to include adolescents
12-15 years old.1The vaccine has been
authorized for use in persons ≥16 years old since
December 2020.
In Brief: Suspension of Johnson & Johnson COVID-19 Vaccine Lifted (online only)
The Medical Letter on Drugs and Therapeutics • May 17, 2021; (Issue 1624)
On April 23, 2021, on advice from the Advisory
Committee on Immunization Practices (ACIP), the
FDA and CDC recommended that use of the Johnson
& Johnson adenovirus-based COVID-19 vaccine
resume despite its...
On April 23, 2021, on advice from the Advisory
Committee on Immunization Practices (ACIP), the
FDA and CDC recommended that use of the Johnson
& Johnson adenovirus-based COVID-19 vaccine
resume despite its association with development of
thrombosis with thrombocytopenia syndrome (TTS).
Administration of the vaccine had been paused on April
13 because of 6 reports of TTS, but after completing a
data review that identified a further 9 cases associated
with the formulation, the agencies concluded that the
benefits of the vaccine outweighed its risks. About
7.98 million doses of the single-dose vaccine had been
administered in the US at the time of the review.
Fluvoxamine for COVID-19?
The Medical Letter on Drugs and Therapeutics • May 3, 2021; (Issue 1623)
A recent article in JAMA and an interview of its senior
author on 60 Minutes have heightened interest in
off-label use of the oral selective serotonin reuptake
inhibitor (SSRI) fluvoxamine (Luvox, and...
A recent article in JAMA and an interview of its senior
author on 60 Minutes have heightened interest in
off-label use of the oral selective serotonin reuptake
inhibitor (SSRI) fluvoxamine (Luvox, and generics) to
treat COVID-19.
In Brief: Johnson & Johnson COVID-19 Vaccine Suspended (online only)
The Medical Letter on Drugs and Therapeutics • May 3, 2021; (Issue 1623)
On April 13, 2021, the FDA and CDC advised suspending
use of the Johnson & Johnson adenovirus-based
COVID-19 vaccine while the agencies investigate 6
cases of cerebral venous sinus thrombosis (CVST)...
On April 13, 2021, the FDA and CDC advised suspending
use of the Johnson & Johnson adenovirus-based
COVID-19 vaccine while the agencies investigate 6
cases of cerebral venous sinus thrombosis (CVST) and
thrombocytopenia that occurred following administration
of the vaccine. In an April 14 emergency meeting,
the Advisory Committee on Immunization Practices
(ACIP) recommended continuing the suspension until
more data become available. About 7 million people in
the US have received the Johnson & Johnson vaccine.
An EUA for Bamlanivimab and Etesevimab for COVID-19
The Medical Letter on Drugs and Therapeutics • April 5, 2021; (Issue 1621)
The FDA has issued an Emergency Use Authorization
(EUA) for Lilly's investigational monoclonal antibodies
bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016)
to be administered together for treatment...
The FDA has issued an Emergency Use Authorization
(EUA) for Lilly's investigational monoclonal antibodies
bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016)
to be administered together for treatment of
mild to moderate COVID-19 in patients ≥12 years old
who weigh ≥40 kg and are at high risk of progressing
to severe disease and/or hospitalization (see Table 1).
Bamlanivimab received an EUA for use as monotherapy
in such patients in November 2020. Regeneron's
investigational monoclonal antibodies casirivimab
(REGN10933) and imdevimab (REGN10987) are also
authorized for use together for the same indication.
FDA Authorizes Johnson & Johnson COVID-19 Vaccine
The Medical Letter on Drugs and Therapeutics • March 22, 2021; (Issue 1620)
On February 27, 2021, the FDA issued an Emergency
Use Authorization (EUA) for the Johnson & Johnson
adenovirus-based vaccine for prevention of COVID-19
in persons ≥18 years old. It is the third...
On February 27, 2021, the FDA issued an Emergency
Use Authorization (EUA) for the Johnson & Johnson
adenovirus-based vaccine for prevention of COVID-19
in persons ≥18 years old. It is the third COVID-19
vaccine to become available in the US and the first to
require only a single dose. Two-dose mRNA-based
vaccines manufactured by Pfizer-BioNTech and
Moderna received EUAs in December 2020.
FDA Authorizes Moderna COVID-19 Vaccine
The Medical Letter on Drugs and Therapeutics • January 25, 2021; (Issue 1616)
On December 18, 2020, the FDA issued an Emergency
Use Authorization (EUA) for the Moderna mRNA-based
vaccine for prevention of COVID-19 in persons
≥18 years old. The Pfizer-BioNTech mRNA-based
vaccine...
On December 18, 2020, the FDA issued an Emergency
Use Authorization (EUA) for the Moderna mRNA-based
vaccine for prevention of COVID-19 in persons
≥18 years old. The Pfizer-BioNTech mRNA-based
vaccine received an FDA EUA for the same indication
in persons ≥16 years old on December 11, 2020.
Antibacterial Drugs for Community-Acquired Pneumonia
The Medical Letter on Drugs and Therapeutics • January 25, 2021; (Issue 1616)
Treatment of community-acquired pneumonia (CAP)
is usually empiric, with selected antibiotic regimens
directed against some of the most common causative
pathogens. Recommended empiric regimens are
listed in...
Treatment of community-acquired pneumonia (CAP)
is usually empiric, with selected antibiotic regimens
directed against some of the most common causative
pathogens. Recommended empiric regimens are
listed in Table 2; recommended antibiotic dosages for
treatment of CAP are listed in Tables 3 and 4. Joint
guidelines for treatment of CAP by the American
Thoracic Society and the Infectious Diseases Society of
America (ATS/IDSA) were updated in 2019.
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine
The Medical Letter on Drugs and Therapeutics • January 11, 2021; (Issue 1615)
The FDA has issued an Emergency Use Authorization
(EUA) for the Pfizer-BioNTech mRNA-based vaccine
for prevention of COVID-19 in persons ≥16 years...
The FDA has issued an Emergency Use Authorization
(EUA) for the Pfizer-BioNTech mRNA-based vaccine
for prevention of COVID-19 in persons ≥16 years old.
An EUA for Casirivimab and Imdevimab for COVID-19
The Medical Letter on Drugs and Therapeutics • December 28, 2020; (Issue 1614)
The FDA has issued an Emergency Use Authorization
(EUA) for Regeneron's investigational monoclonal
antibodies casirivimab and imdevimab (REGEN-COV)
to be administered together by IV infusion or SC
injection...
The FDA has issued an Emergency Use Authorization
(EUA) for Regeneron's investigational monoclonal
antibodies casirivimab and imdevimab (REGEN-COV)
to be administered together by IV infusion or SC
injection for treatment of mild to moderate COVID-19
in adults and pediatric patients (≥12 years old and
weigh ≥40 kg) who are at high risk of progressing to
severe COVID-19 and/or hospitalization.
An EUA for Baricitinib (Olumiant) for COVID-19
The Medical Letter on Drugs and Therapeutics • December 28, 2020; (Issue 1614)
The oral Janus kinase (JAK) inhibitor baricitinib
(Olumiant – Lilly) has been granted an FDA Emergency
Use Authorization (EUA) for treatment of confirmed or
suspected COVID-19 in hospitalized patients ≥2...
The oral Janus kinase (JAK) inhibitor baricitinib
(Olumiant – Lilly) has been granted an FDA Emergency
Use Authorization (EUA) for treatment of confirmed or
suspected COVID-19 in hospitalized patients ≥2 years
old who require supplemental oxygen, mechanical
ventilation, or extracorporeal membrane oxygenation
(ECMO); the EUA requires that baricitinib be used
in combination with the IV antiviral drug remdesivir
(Veklury). Baricitinib has been available for treatment
of rheumatoid arthritis since 2018. Remdesivir was
recently approved by the FDA for treatment of COVID-19
in hospitalized patients ≥12 years old who weigh ≥40
kg; it is available under an EUA for treatment of other
hospitalized patients.
Ofatumumab (Kesimpta) for Multiple Sclerosis
The Medical Letter on Drugs and Therapeutics • December 28, 2020; (Issue 1614)
The FDA has approved a subcutaneous formulation
of the recombinant human anti-CD20 antibody
ofatumumab (Kesimpta – Novartis) for treatment
of adults with relapsing forms of multiple sclerosis
(MS),...
The FDA has approved a subcutaneous formulation
of the recombinant human anti-CD20 antibody
ofatumumab (Kesimpta – Novartis) for treatment
of adults with relapsing forms of multiple sclerosis
(MS), including clinically isolated syndrome (initial
neurological episode), relapsing-remitting disease,
and active secondary progressive MS (SPMS).
Kesimpta is the second anti-CD20 antibody to be
approved for these indications; IV ocrelizumab
(Ocrevus), which is also approved for treatment
of primary progressive MS, was the first. An IV
formulation of ofatumumab (Arzerra) has been
available for treatment of chronic lymphocytic
leukemia (CLL) since 2010.
An EUA for Bamlanivimab - A Monoclonal Antibody for COVID-19
The Medical Letter on Drugs and Therapeutics • November 30, 2020; (Issue 1612)
The investigational neutralizing IgG1 monoclonal
antibody bamlanivimab (LY-CoV555; Lilly) has
been granted an FDA Emergency Use Authorization
(EUA) for treatment of recently diagnosed mild
to moderate...
The investigational neutralizing IgG1 monoclonal
antibody bamlanivimab (LY-CoV555; Lilly) has
been granted an FDA Emergency Use Authorization
(EUA) for treatment of recently diagnosed mild
to moderate COVID-19 in patients who are ≥12
years old, weigh at least 40 kg, and are at high
risk for progressing to severe disease and/or
hospitalization (see Table 1).
Remdesivir (Veklury) for COVID-19
The Medical Letter on Drugs and Therapeutics • November 30, 2020; (Issue 1612)
The FDA has approved the antiviral drug remdesivir
(Veklury – Gilead) for IV treatment of COVID-19 in
hospitalized patients who are ≥12 years old and weigh
≥40 kg. Hospitalized children who are...
The FDA has approved the antiviral drug remdesivir
(Veklury – Gilead) for IV treatment of COVID-19 in
hospitalized patients who are ≥12 years old and weigh
≥40 kg. Hospitalized children who are <12 years old
or weigh <40 kg can receive remdesivir through an
Emergency Use Authorization (EUA). Remdesivir is
the first drug to be approved in the US for treatment
of COVID-19.
Drugs for Acne
The Medical Letter on Drugs and Therapeutics • November 30, 2020; (Issue 1612)
Acne is common among adolescents and young adults,
but its prevalence appears to have increased in people
of all ages due to prolonged wearing of masks during
the COVID-19 pandemic. Guidelines for treatment...
Acne is common among adolescents and young adults,
but its prevalence appears to have increased in people
of all ages due to prolonged wearing of masks during
the COVID-19 pandemic. Guidelines for treatment of
acne were last published in 2016.
Antiviral Drugs for Influenza for 2020-2021
The Medical Letter on Drugs and Therapeutics • November 2, 2020; (Issue 1610)
Influenza is generally a self-limited illness, but
complications such as pneumonia, respiratory failure,
and death can occur, especially in patients at increased
risk for influenza complications (see Table...
Influenza is generally a self-limited illness, but
complications such as pneumonia, respiratory failure,
and death can occur, especially in patients at increased
risk for influenza complications (see Table 1).
Antiviral drugs recommended for treatment and
chemoprophylaxis of influenza this season are listed
in Table 2. Updated information on influenza activity
and antiviral resistance is available from the CDC at
www.cdc.gov/flu.
Timing of Remdesivir for COVID-19
The Medical Letter on Drugs and Therapeutics • October 19, 2020; (Issue 1609)
Remdesivir (Veklury – Gilead), an investigational
antiviral drug administered by IV infusion, is now
available through an FDA Emergency Use Authorization
(EUA) for treatment of COVID-19 in all...
Remdesivir (Veklury – Gilead), an investigational
antiviral drug administered by IV infusion, is now
available through an FDA Emergency Use Authorization
(EUA) for treatment of COVID-19 in all hospitalized
patients. An earlier EUA limited use of the drug to
patients hospitalized with severe disease.
Some Drugs for COVID-19
The Medical Letter on Drugs and Therapeutics • April 6, 2020; (Issue 1595)
The severity and rapid spread of COVID-19 (caused by SARS-CoV-2) have raised questions about the use of some drugs in patients with the disease and whether currently available drugs could be effective in...
The severity and rapid spread of COVID-19 (caused by SARS-CoV-2) have raised questions about the use of some drugs in patients with the disease and whether currently available drugs could be effective in treating it. Definitive answers are lacking, but some recommendations can be made. For additional information on specific drugs, see our table Some Drugs Being Considered for Treatment of COVID-19.
Table: Treatments Considered for COVID-19 (Archived) (online only)
The Medical Letter on Drugs and Therapeutics • April 6, 2020; (Issue 1595)
...
View the Table: Treatments Considered for COVID-19