The FDA has approved oral and injectable formulations of the HIV-1 capsid inhibitor lenacapavir (Sunlenca – Gilead) for use with other antiretroviral drugs to treat multidrug-resistant HIV-1 infection (MDR-HIV) in heavily treatment-experienced adults whose current regimen is failing. Lenacapavir is the third drug to be approved exclusively for treatment of MDR-HIV; the intravenously administered CD4-directed antibody ibalizumab-uiyk (Trogarzo) and the orally administered HIV-1 gp120-directed attachment inhibitor fostemsavir (Rukobia) were approved earlier.

View the Vaccination Recommendations for Bivalent mRNA COVID-19 Vaccines

The FDA has approved insulin degludec (Tresiba – Novo Nordisk) for treatment of adults with type 1 or type 2 diabetes. Insulin degludec is the third long-acting human insulin analog to be approved by the FDA; insulin detemir (Levemir) and insulin glargine (Lantus, Toujeo) were approved earlier.

The FDA has approved ceftolozane/tazobactam (Zerbaxa – Cubist), a combination of a new cephalosporin antibiotic and a beta-lactamase inhibitor, for intravenous treatment of complicated urinary tract and intra-abdominal infections in adults.

The FDA has approved Vuity (Abbvie), a 1.25% ophthalmic solution of the muscarinic receptor agonist pilocarpine hydrochloride, for treatment of presbyopia in adults. Pilocarpine 1%, 2%, and 4% ophthalmic solutions (Isopto Carpine, and others) have been available for years for treatment of glaucoma, but local and systemic adverse effects have limited their use.

Diet, exercise, and weight loss can improve glycemic control, but most patients with type 2 diabetes eventually require glucose-lowering pharmacotherapy. An A1C goal of <7% (while minimizing hypoglycemia) is recommended for most patients to prevent or reduce the microvascular complications of diabetes (retinopathy, nephropathy, neuropathy). An A1C target of <8% may be appropriate for patients who are older, have comorbid conditions, or are at risk of serious hypoglycemia-associated adverse events.

The FDA has amended its Emergency Use Authorizations (EUAs) for the bivalent mRNA COVID-19 vaccines (original and Omicron BA.4/5 strains) manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit their use for all doses administered to persons ≥6 months old. The monovalent Pfizer and Moderna vaccines are no longer authorized for use in the US

Mirabegron (mir a beg’ ron; Myrbetriq [meer BEH trick] – Astellas), a beta-3 adrenergic agonist, has been approved by the FDA for the treatment of overactive bladder. It is the first beta-3 adrenergic agonist to be approved for any indication in the US. Mirabegron has been marketed in Japan since 2011. OnabotulinumtoxinA (Botox) was also recently approved by the FDA for treatment of overactive bladder and will be reviewed in a future issue.

The FDA has approved Winlevi (Sun), a 1% cream formulation of the androgen receptor inhibitor clascoterone, for treatment of acne vulgaris in patients ≥12 years old. It is the first topical androgen receptor inhibitor to be approved by the FDA.

The FDA has approved Vizz (Lenz Therapeutics), a 1.44% ophthalmic solution of the cholinergic agonist aceclidine, for treatment of presbyopia in adults. Aceclidine has been available in the EU for years for treatment of open-angle glaucoma.