Matching articles for "COVID-19"

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.
Med Lett Drugs Ther. 2022 Oct 3;64(1660):159-60 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Oct 3;64(1660):e160 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):121-2 | Show Full IntroductionHide Full Introduction

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
Med Lett Drugs Ther. 2022 Aug 8;64(1656):e122-3 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):e124 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Jul 25;64(1655):113-20 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Jul 11;64(1654):110-2 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Jul 11;64(1654):112 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Jun 13;64(1652):95-6 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Jun 13;64(1652):e2-3 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Jun 13;64(1652):94 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Jun 13;64(1652):94-5 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Jun 13;64(1652):e1 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Apr 18;64(1648):63-4 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Mar 21;64(1646):41-2 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Mar 21;64(1646):47-8 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Feb 21;64(1644):31-2 | Show Full IntroductionHide Full Introduction

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
Med Lett Drugs Ther. 2022 Jan 28;64(1643):e1 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Jan 24;64(1642):10-1 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Jan 24;64(1642):9-10 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Jan 24;64(1642):16 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2022 Jan 10;64(1641):1-2 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Dec 27;63(1640):201-2 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Nov 29;63(1638):185 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Nov 29;63(1638):186-8 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Nov 15;63(1637):177-84 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Oct 18;63(1635):161-2 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Oct 18;63(1635):163-4 | Show Full IntroductionHide Full Introduction

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).
Med Lett Drugs Ther. 2021 Sep 20;63(1633):145-6 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Aug 23;63(1631):130-1 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Aug 9;63(1630):123-5 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Aug 9;63(1630):121 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Jul 26;63(1629):113-4 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Jun 28;63(1627):97-8 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 May 31;63(1625):81 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 May 17;63(1624):e1 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 May 3;63(1623):69-70 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 May 3;63(1623):e1 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Apr 5;63(1621):49-50 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Mar 22;63(1620):41-2 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Jan 25;63(1616):9-10 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Jan 25;63(1616):10-5 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2021 Jan 11;63(1615):1-2 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2020 Dec 28;62(1614):201-2 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2020 Dec 28;62(1614):202-3 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2020 Dec 28;62(1614):203-5 | Show Full IntroductionHide Full Introduction

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).
Med Lett Drugs Ther. 2020 Nov 30;62(1612):185-6 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2020 Nov 30;62(1612):186-8 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2020 Nov 30;62(1612):188-91 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2020 Nov 2;62(1610):169-73 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2020 Oct 19;62(1609):161 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2020 Apr 6;62(1595):49-50 | Show Full IntroductionHide Full Introduction

Table: Treatments Considered for COVID-19 (online only)

   
The Medical Letter on Drugs and Therapeutics • April 6, 2020;  (Issue 1595)
...
View the Table: Treatments Considered for COVID-19
Med Lett Drugs Ther. 2020 Apr 6;62(1595):e1-289 | Show Full IntroductionHide Full Introduction