The oral glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Rybelsus – Novo Nordisk), which was approved by the FDA in 2019 for treatment of type 2 diabetes in adults, has now also been approved to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who are at high risk for these events. The injectable GLP-1 receptor agonists semaglutide (Ozempic), dulaglutide (Trulicity), and liraglutide (Victoza) are also approved for cardiovascular risk reduction in patients with type 2 diabetes (see Table 1).

Teprotumumab-trbw (Tepezza - Horizon), an insulin-like growth factor-1 receptor (IGF-1R) inhibitor, has been approved by the FDA for IV treatment of thyroid eye disease. It is the first drug to be approved in the US for this indication.

The B-lymphocyte stimulator (BLyS)-specific inhibitor belimumab (Benlysta – GSK), which was approved earlier for treatment of active, autoantibody-positive, nonrenal, systemic lupus erythematosus (SLE), has now been approved for use in addition to standard therapy for treatment of active lupus nephritis in adults. Belimumab is the first drug to be approved in the US for treatment of both SLE and lupus nephritis.

The FDA has approved an expansion of the peripheral artery disease (PAD) indication for the oral direct factor Xa inhibitor rivaroxaban (Xarelto – Janssen) to include patients who have recently undergone a lower extremity revascularization procedure for symptomatic PAD (see Table 1). Rivaroxaban is the first direct oral anticoagulant (DOAC) to be approved for use in patients with PAD.

Delandistrogene moxeparvovec-rokl (Elevidys – Sarepta), an adeno-associated virus (AAV) vector-based gene therapy, has received accelerated approval from the FDA for treatment of ambulatory children 4-5 years old with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the dystrophin gene. It is the first gene therapy to be approved in the US for treatment of DMD. Accelerated approval was based on expression of microdystrophin in skeletal muscle, a surrogate endpoint.

The FDA has approved datopotamab deruxtecan (Datroway – Daiichi Sankyo/AstraZeneca), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Sunvozertinib (Zegfrovy – Dizal), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations who had disease progression on or after platinum-based chemotherapy.

The FDA has approved a 12.5-mg tablet formulation of the thiazide-like diuretic chlorthalidone (HemiClor – Ingenus) for treatment of hypertension. Chlorthalidone has been available for years in 15-, 25-, and 50-mg tablets (Thalitone, and generics) and in fixed-dose combinations with azilsartan medoxomil (Edarbyclor) and atenolol (Tenoretic, and generics).

The FDA has approved the complement C5 inhibitor avacincaptad pegol (Izervay – Iveric) for intravitreal treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Avacincaptad pegol is the second complement inhibitor to be approved in the US for this indication; pegcetacoplan (Syfovre), a complement C3 and C3b inhibitor, was approved earlier.

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.