1
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. 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.
2
In Brief: Finerenone (Kerendia) for Diabetic Kidney Disease
The Medical Letter on Drugs and Therapeutics • January 23, 2023; (Issue 1668)
Recently published guidelines from the American
Diabetes Association (ADA) and the Kidney Disease:
Improving Global Outcomes (KDIGO) Diabetes Work
Group recommend addition of the oral nonsteroidal
mineralocorticoid receptor antagonist (MRA)
finerenone (Kerendia) to standard treatment in
patients with type 2 diabetes and chronic kidney
disease (CKD).
3
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.
4
In Brief: Furoscix - A Subcutaneous Furosemide Infusor for Heart Failure
The Medical Letter on Drugs and Therapeutics • January 23, 2023; (Issue 1668)
The FDA has approved Furoscix (scPharmaceuticals),
a subcutaneous formulation of the loop diuretic
furosemide administered via a single-use, on-body
infusor, for treatment of congestion due to fluid
overload in adults with New York Heart Association
(NYHA) Class II-III chronic heart failure (HF).
Furosemide (Lasix, and generics) has been available
for years in oral and IV formulations.
5
In Brief: A New Indication for Dabrafenib (Tafinlar) and Trametinib (Mekinist) Combination Therapy (online only)
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
The oral kinase inhibitors dabrafenib (Tafinlar – GSK)
and trametinib (Mekinist – Novartis) have received
accelerated approval by the FDA for use together
for a fifth indication: treatment of unresectable or
metastatic solid tumors with a BRAF V600E mutation
in patients ≥6 years old who have progressed
following prior treatment and have no satisfactory
alternative treatment options. The combination is not
approved for treatment of colorectal cancer because
of known intrinsic resistance to BRAF inhibition and
dabrafenib is not approved for use in patients with
wild-type BRAF melanoma, anaplastic thyroid cancer
(ATC), or solid tumors.
6
Lecanemab (Leqembi) for Alzheimer's Disease
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
Lecanemab-irmb (Leqembi – Biogen/Eisai), an IV
amyloid beta-directed monoclonal antibody, has
received accelerated approval from the FDA for
treatment of Alzheimer's disease. The label states
that treatment with Leqembi should be initiated in
patients with mild cognitive impairment (MCI) or
mild dementia, the population in which the drug was
initiated in clinical trials. Lecanemab is the second
IV amyloid-beta directed monoclonal antibody to be
approved for this indication; aducanumab (Aduhelm)
was approved in 2021 and has the same restrictions
on treatment initiation.
7
Hemgenix - A Gene Therapy for Hemophilia B
The Medical Letter on Drugs and Therapeutics • January 23, 2023; (Issue 1668)
Etranacogene dezaparvovec-drlb (Hemgenix – CSL
Behring), an adeno-associated virus vector-based
gene therapy, has been approved by the FDA for
treatment of hemophilia B in adults who currently
receive factor IX prophylaxis therapy or have had
life-threatening or repeated, serious, spontaneous
bleeding episodes. It is the first gene therapy to be
approved in the US for this indication.
8
Dupilumab (Dupixent) for Eosinophilic Esophagitis and Prurigo Nodularis
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
The FDA has approved the subcutaneously
injected interleukin (IL)-4 receptor alpha antagonist
dupilumab (Dupixent – Sanofi/Regeneron)
for treatment of eosinophilic esophagitis (EoE)
in patients ≥12 years old who weigh ≥40 kg and
treatment of prurigo nodularis in adults. Dupilumab
is the first drug to be approved in the US for each
of these indications. It is also FDA-approved for
treatment of atopic dermatitis, asthma, and chronic
rhinosinusitis with nasal polyposis.
9
Epsolay - A Benzoyl Peroxide Cream for Rosacea
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
Epsolay (Galderma), a 5% benzoyl peroxide cream,
has been approved by the FDA for treatment of
inflammatory lesions of rosacea in adults. It is the first
product containing benzoyl peroxide to be approved
in the US for treatment of rosacea. Benzoyl peroxide
formulations approved for acne have been used off-label
to treat rosacea for years, but itching and burning
have limited their use.
10
Transdermal Dextroamphetamine (Xelstrym) for ADHD
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
The FDA has approved a dextroamphetamine
transdermal patch (Xelstrym – Noven) for once-daily
treatment of attention-deficit/hyperactivity disorder
(ADHD) in patients ≥6 years old. Xelstrym is the first
transdermal amphetamine product to be approved
in the US. A methylphenidate transdermal patch
(Daytrana, and generics) has been available for years
for treatment of ADHD.