The antisense oligonucleotide viltolarsen (Viltepso – NS Pharma) has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have mutations of the dystrophin gene that are amenable to exon 53 skipping (DMD-53). It is the second drug to be approved for this indication; the antisense oligonucleotide golodirsen (Vyondys 53) was approved in 2019.

Lecanemab-irmb (Leqembi – Eisai/Biogen), the IV amyloid-directed monoclonal antibody that received accelerated approval from the FDA in January 2023 for treatment of early Alzheimer's disease, has now received full approval from the FDA based on a trial showing that it slowed cognitive and functional decline in patients with mild cognitive impairment (MCI) or mild Alzheimer's disease dementia and confirmed presence of brain amyloid. The IV amyloid-directed monoclonal antibody aducanumab (Aduhelm) has received only an accelerated FDA-approval for the same indication.

Terbinafine 1% cream (Lamisil - Sandoz), an allylamine synthetic antifungal drug chemically related to naftifine (Naftin - Medical Letter, 30:98, 1988), is now available in the USA for topical treatment of tinea pedis, tinea cruris, and tinea corporis infections. An oral formulation is available in Europe and is under investigation here.

Fosfomycin, a broad-spectrum antibiotic used parenterally in Europe for many years, has been approved by the US Food and Drug Administration (FDA) as fosfomycin tromethamine (Monurol - Forest) for single-dose oral treatment of uncomplicated urinary tract infections in women.

Palivizumab (Synagis - MedImmune), an injectable monoclonal antibody, has been marketed in the USA since 1999 for prevention of respiratory syncytial virus (RSV) disease in high-risk infants and children.

The FDA, which had previously approved intravenous (IV) administration of 5 mg of zoledronic acid (Reclast – Novartis) once a year for treatment of postmenopausal osteoporosis (Med Lett Drugs Ther 2007; 49:89), has now approved the same dose for use once every 2 years to prevent osteoporosis in postmenopausal women with osteopenia.Clinical Studies – In an unpublished study summarized in the package insert, 224 women with osteopenia ≤5 years after menopause were given an IV infusion of zoledronic acid 5 mg or placebo; 2 years later, total hip bone mineral density (BMD) had increased by...

The FDA has approved a once-weekly extendedrelease formulation of exenatide (Bydureon – Amylin), an injectable glucagon-like peptide-1 (GLP-1) receptor agonist, for treatment of type 2 diabetes.

Perampanel (per am’ pa nel; Fycompa – Eisai), a first-in-class noncompetitive AMPA receptor antagonist, has been approved by the FDA for adjunctive treatment of partial-onset seizures in patients ≥12 years old. New drugs for epilepsy are often initially approved by the FDA as adjunctive treatment for partial seizures.

The FDA has approved golimumab (Simponi – Janssen), a fully human monoclonal antibody specific for tumor necrosis factor (TNF) alpha, for induction and maintenance of remission in patients with moderate to severe ulcerative colitis who do not respond to or cannot tolerate other therapies or who require continuous treatment with corticosteroids. Golimumab was approved earlier for treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It is the third TNF inhibitor to be approved for use in ulcerative colitis.

The FDA has approved Xtampza ER (Collegium), a new extended-release, abuse-deterrent capsule formulation of oxycodone, for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.