1
In Brief: Alternatives to Adderall
The Medical Letter on Drugs and Therapeutics • November 28, 2022; (Issue 1664)
The short-acting formulation of mixed amphetamine
salts (Adderall, and generics) FDA-approved for
treatment of attention-deficit hyperactivity disorder
(ADHD) and narcolepsy, is currently in short supply in
the US. Until an adequate supply is restored, patients
may be looking for alternatives.
2
COVID-19 Update: Novavax Vaccine for 2024-2025
The Medical Letter on Drugs and Therapeutics • October 28, 2024; (Issue 1714)
A 2024-2025 formulation of the Novavax adjuvanted
protein subunit COVID-19 vaccine that more
closely targets currently circulating SARS-CoV-2
variants is available now under an FDA Emergency
Use Authorization (EUA) for use in persons ≥12
years old. The 2024-2025 formulations of the
mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) were licensed by the FDA last month for use in persons ≥12
years old and made available under EUAs for use in
persons 6 months to 11 years old.
3
In Brief: Subcutaneous Ocrelizumab (Ocrevus Zunovo) for Multiple Sclerosis
The Medical Letter on Drugs and Therapeutics • October 28, 2024; (Issue 1714)
Ocrevus Zunovo (Genentech), a subcutaneous (SC)
formulation of the anti-CD20 monoclonal antibody
ocrelizumab plus human recombinant hyaluronidase-ocsq
has been approved by the FDA for treatment of
primary progressive and relapsing forms of multiple
sclerosis (MS). Intravenous ocrelizumab (Ocrevus),
which was approved for the same indications in 2017,
is one of the most commonly prescribed drugs for
treatment of MS. Ocrelizumab remains the only drug
approved for treatment of primary progressive MS.
4
In Brief: FluMist Influenza Vaccine for Self-Administration
The Medical Letter on Drugs and Therapeutics • October 28, 2024; (Issue 1714)
FluMist (AstraZeneca), the live-attenuated intranasal
influenza vaccine that has been available for
years for administration by a healthcare provider
in nonpregnant persons 2-49 years old, has now
been approved by the FDA for self- or caregiver-administration.
It is expected to be available for such
use during the 2025-2026 influenza season. FluMist
is only available through a healthcare provider
this season. It will continue to be available for
administration by a healthcare provider in the future
5
Capvaxive – A 21-Valent Pneumococcal Conjugate Vaccine
The Medical Letter on Drugs and Therapeutics • October 14, 2024; (Issue 1713)
The FDA has licensed Capvaxive (PCV21; Merck),
a 21-valent pneumococcal conjugate vaccine, for
prevention of invasive pneumococcal disease (IPD)
and pneumococcal pneumonia in adults. Four other
pneumococcal vaccines are currently available in the
US: Prevnar 20 (PCV20), Vaxneuvance (PCV15), and
Prevnar 13 (PCV13) are conjugate vaccines licensed
for use in persons ≥6 weeks old, and Pneumovax 23
(PPSV23) is a pneumococcal polysaccharide vaccine
licensed for use in persons ≥2 years old (see Table 1).
6
In Brief: OTC Ivermectin for Head Lice
The Medical Letter on Drugs and Therapeutics • June 26, 2023; (Issue 1679)
Topical ivermectin lotion 0.5% (Sklice, and generics),
which has been available by prescription since 2012,
is now FDA-approved for sale over the counter (OTC)
for treatment of head lice in patients ≥6 months old.
Ivermectin is also available by prescription as a 1%
cream (Soolantra) approved for topical treatment of
inflammatory lesions of rosacea and in oral tablets
(Stromectol, and generics) for treatment of various
parasitic infections.
7
In Brief: A New Non-Small Cell Lung Cancer Indication for Osimertinib (Tagrisso) (online only)
The Medical Letter on Drugs and Therapeutics • November 11, 2024; (Issue 1715)
The oral kinase inhibitor osimertinib (Tagrisso –
AstraZeneca), which has been available for years for
treatment of non-small cell lung cancer (NSCLC) in
adults with epidermal growth factor receptor (EGFR)
exon 19 deletions or exon 21 L858R mutations, has now
been approved for treatment of unresectable stage III
EGFR-mutated NSCLC. About 20-30% of patients with
NSCLC have locally advanced stage III NSCLC, and
60-90% of these patients have unresectable disease.
Osimertinib is the first targeted therapy to be approved
for the new indication.
8
Drugs for Hepatitis C Virus Infection
The Medical Letter on Drugs and Therapeutics • October 28, 2024; (Issue 1714)
About 2.5 million persons in the US had hepatitis C
between 2017 and 2020. Guidelines from the American
Association for the Study of Liver Diseases (AASLD)
and the Infectious Diseases Society of America (IDSA)
on management of hepatitis C virus (HCV) infection
were updated in 2023.
9
A New RSV Vaccine (mResvia) for Adults ≥60 Years Old
The Medical Letter on Drugs and Therapeutics • October 14, 2024; (Issue 1713)
TThe FDA has licensed mResvia (Moderna), an
mRNA respiratory syncytial virus (RSV) vaccine, for
prevention of lower respiratory tract disease (LRTD)
caused by RSV in adults ≥60 years old. It is the first mRNA vaccine to be licensed in the US for this
indication. Two recombinant RSV vaccines, Arexvy
and Abrysvo, are also available for prevention of RSV
LRTD. Arexvy is approved for use in adults ≥50 years
old. Abrysvo is approved for use in adults ≥60 years
old and in pregnant women to prevent RSV LRTD in
their infants.
10
Xanomeline/Trospium (Cobenfy) for Schizophrenia
The Medical Letter on Drugs and Therapeutics • November 11, 2024; (Issue 1715)
The FDA has approved Cobenfy (BMS), an oral
fixed-dose combination of the muscarinic agonist
xanomeline and the peripheral muscarinic antagonist
trospium chloride, for treatment of schizophrenia in
adults. It is the first antipsychotic drug to be approved
in the US for treatment of schizophrenia that does not
block dopamine receptors. This is the first approval
for xanomeline; trospium has been available for many
years for treatment of overactive bladder.