The FDA recently expanded the eligibility criteria (see Table 1) for treatment with the surgically implanted hypoglossal nerve stimulation system (Inspire Upper Airway Stimulation – Inspire Medical Systems). The device has been advertised lately on radio and television.

The centuries-old anti-inflammatory drug colchicine (Colcrys, and others) is FDA-approved for prophylaxis and treatment of gout flares and for treatment of familial Mediterranean fever. It is also used off-label to treat pericarditis, and in recent years has been investigated for reduction of cardiovascular risk in patients with coronary artery disease (CAD).

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Ozempic – Novo Nordisk) has been approved by the FDA to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). It is the first GLP-1 receptor agonist to be approved in the US for this indication.

The FDA has approved a long-acting fixed-dose combination of the stimulant dexmethylphenidate and the prodrug serdexmethylphenidate (Azstarys – Corium) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old. Azstarys is the first product containing serdexmethylphenidate to become available in the US.

View the Comparison Table: Some Oral Anticoagulants for VTE

The FDA has approved the oral GABA_A receptor modulator zuranolone (Zurzuvae – Sage Therapeutics/Biogen) for treatment of postpartum depression (PPD). Zuranolone is the second drug to be approved for this indication; brexanolone (Zulresso), another GABA_A receptor modulator, was approved for IV treatment of PPD in 2019.

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.

View the Comparison Table: Drugs for Parkinson's Disease

Lonapegsomatropin-tcgd (Skytrofa – Ascendis), a long-acting prodrug of recombinant human growth hormone (rhGH), has been approved by the FDA for once-weekly subcutaneous (SC) treatment of growth failure due to inadequate secretion of endogenous growth hormone in children ≥1 year old who weigh ≥11.5 kg. It is the first once-weekly rhGH product to be approved in the US; other available rhGH formulations are administered more frequently.

The FDA has approved inclisiran (Leqvio – Novartis), a small interfering RNA (siRNA) directed to proprotein convertase subtilisin/kexin type 9 (PCSK9) mRNA, as an adjunct to diet and maximally tolerated statin therapy for subcutaneous (SC) treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Inclisiran is the first FDA-approved PCSK9-directed siRNA therapeutic agent.