1
Resmetirom (Rezdiffra) for Metabolic Dysfunction-Associated Steatohepatitis
The Medical Letter on Drugs and Therapeutics • April 29, 2024; (Issue 1701)
Resmetirom (Rezdiffra – Madrigal), a thyroid hormone
receptor-beta agonist, has received accelerated
approval from the FDA for treatment of noncirrhotic
nonalcoholic steatohepatitis (NASH) with moderate
to advanced fibrosis in adults. NASH has recently
been renamed metabolic dysfunction-associated
steatohepatitis (MASH). Resmetirom is the first drug
to be approved in the US for this indication.
2
Antibiotic Prophylaxis for Dental Procedures
The Medical Letter on Drugs and Therapeutics • April 29, 2024; (Issue 1701)
Since 2007, antimicrobial prophylaxis for dental
procedures has been recommended to prevent
viridans group streptococcal infective endocarditis
only for patients at highest risk of an adverse
outcome. Limiting use to such patients does not
appear to have led to an increased incidence of
infective endocarditis or increased mortality due to
infective endocarditis.
3
A New Indication for Semaglutide (Wegovy)
The Medical Letter on Drugs and Therapeutics • April 29, 2024; (Issue 1701)
The injectable glucagon-like peptide-1 (GLP-1)
receptor agonist semaglutide (Wegovy) has been
approved by the FDA to reduce the risk of major
adverse cardiovascular events (MACE) in adults with
established cardiovascular disease (CVD) and either
obesity or overweight. Semaglutide is the first drug
to be approved for cardiovascular risk reduction in
this population. It is also approved in a lower-dose
injectable formulation as Ozempic and in an oral
formulation as Rybelsus (see Table 1).
4
Intravenous Acetaminophen/Ibuprofen (Combogesic IV)
The Medical Letter on Drugs and Therapeutics • April 29, 2024; (Issue 1701)
The FDA has approved Combogesic IV (Hikma), an IV
solution containing acetaminophen and ibuprofen, to
treat mild to moderate pain (alone) or moderate to
severe pain (in combination with an opioid) in adults
when IV analgesia is considered clinically necessary.
Single-drug IV solutions containing ibuprofen
(Caldolor) and acetaminophen have been available in
the US for years.
5
iDose TR — A Travoprost Implant for Glaucoma
The Medical Letter on Drugs and Therapeutics • April 29, 2024; (Issue 1701)
The FDA has approved iDose TR (Glaukos), an
intracameral implant containing the prostaglandin
analog (PGA) travoprost, for reduction of intraocular
pressure (IOP) in patients with open-angle glaucoma
or ocular hypertension. Travoprost is also available
as a topical ophthalmic solution (Travatan Z, and
generics) for the same indication. iDose TR is the
second ocular implant to become available in the US
for this indication; Durysta, an intracameral implant
containing the prostaglandin analog bimatoprost,
was the first.
6
Roflumilast Foam (Zoryve) for Seborrheic Dermatitis
The Medical Letter on Drugs and Therapeutics • April 15, 2024; (Issue 1700)
The FDA has approved a 0.3% foam formulation of
the phosphodiesterase-4 (PDE4) inhibitor roflumilast
(Zoryve – Arcutis) for topical treatment of seborrheic
dermatitis in patients ≥9 years old. Roflumilast is
the first PDE4 inhibitor to be approved in the US for
this indication. It is also available in a 0.3% cream
formulation (Zoryve) for treatment of plaque psoriasis
and in an oral formulation (Daliresp, and generics) for
treatment of chronic obstructive pulmonary disease.
A 0.15% cream formulation for treatment of atopic
dermatitis in patients ≥6 years old will be reviewed by
the FDA in July.
7
Cabtreo: A Three-Drug Gel for Acne
The Medical Letter on Drugs and Therapeutics • April 15, 2024; (Issue 1700)
The FDA has approved Cabtreo (Bausch Health), a gel
containing the retinoid adapalene, the oxidizing agent
benzoyl peroxide, and the antibiotic clindamycin, for
treatment of acne vulgaris in patients ≥12 years old.
Cabtreo is the first three-drug topical formulation to
become available in the US for treatment of acne.
8
Donislecel (Lantidra) for Type 1 Diabetes
The Medical Letter on Drugs and Therapeutics • April 15, 2024; (Issue 1700)
The FDA has approved donislecel-jujn (Lantidra –
CellTrans), an allogeneic pancreatic islet
cellular therapy, for use in conjunction with
immunosuppression for treatment of adults with
type 1 diabetes who are unable to approach target
HbA1c because of current repeated episodes of
severe hypoglycemia despite intensive diabetes
management and education. Donislecel is the first
cell-based treatment to be approved in the US for
type 1 diabetes.
9
Zilucoplan (Zilbrysq) for Myasthenia Gravis
The Medical Letter on Drugs and Therapeutics • April 15, 2024; (Issue 1700)
The FDA has approved the complement C5
inhibitor zilucoplan (Zilbrysq – UCB) for once-daily
subcutaneous treatment of generalized myasthenia
gravis (gMG) in adults who are anti-acetylcholine
receptor (AChR) antibody-positive. Zilucoplan is
the first complement inhibitor to be approved for
treatment of myasthenia gravis that can be self-administered.
Two IV complement inhibitors,
eculizumab (Soliris) and ravulizumab (Ultomiris),
were approved earlier.
10
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.