The FDA has approved Juluca (ViiV Healthcare/Janssen), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay) and the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (Edurant), as a once-daily complete regimen for treatment of adults with HIV-1 infection who do not have a history of treatment failure or known substitutions associated with resistance to either drug and have been taking a stable suppressive antiretroviral regimen for ≥6 months. Dolutegravir/rilpivirine is the first complete regimen to be approved for...

Oral semaglutide 1.5-, 4-, and 9-mg tablets, which were previously approved by the FDA (but never marketed) as the R2 formulation of Rybelsus, have now been approved as Ozempic (see Table 1). Both the original R1 formulation of Rybelsus (3-, 7-, and 14-mg tablets) and the renamed Ozempic tablets are FDA-approved for treatment of type 2 diabetes and to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who are at risk for these events. The R1 (Rybelsus) and R2 (Ozempic) formulations are not interchangeable on a mg-per-mg basis; Ozempic...

Claims for the superiority of various calcium supplements are now appearing on television and in the print media. A high calcium intake combined with vitamin D can increase bone density and reduce the incidence of fractures in older women and probably also in men.

Ciclesonide (Omnaris - Sepracor/Nycomed), a once daily corticosteroid nasal spray, is now available for treatment of seasonal allergic rhinitis (SAR) in adults and children ≥6 years old and for perennial allergic rhinitis (PAR) in those ≥12 years old. An orally inhaled formulation of ciclesonide (Alvesco) was recently approved by the FDA for maintenance treatment of asthma, and will be reviewed in a future issue of The Medical Letter

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.

Lantaoprost, a prostaglandin F2-alpha analog, has been approved by the FDA for topical treatment of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension refractory to other drugs.

The nasal spray formulation of the corticosteroid fluticasone furoate is now available over the counter (OTC) as Flonase Sensimist Allergy Relief (GSK) in the same strength as the prescription product (Veramyst) for treatment of seasonal or perennial allergic rhinitis. It is the fourth intranasal corticosteroid to become available OTC.

Teclistamab-cqyv (Tecvayli – Janssen), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, has been granted accelerated approval by the FDA for treatment of relapsed or refractory multiple myeloma in adults who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Accelerated approval was based on response rate. Teclistamab is the first bispecific BCMA-directed CD3 T-cell engager to be approved in the US.

Dupilumab (Dupixent – Sanofi/Regeneron), a subcutaneously injected interleukin (IL)-4 receptor alpha antagonist that is FDA-approved for several indications, including treatment of chronic rhinosinusitis with nasal polyps, has now been approved for treatment of allergic fungal rhinosinusitis (AFRS) in patients ≥6 years old who previously had sinonasal surgery. It is the first drug to be approved in the US for this indication.

The FDA has approved the antiviral drug remdesivir (Veklury – Gilead) for IV treatment of COVID-19 in hospitalized patients who are ≥12 years old and weigh ≥40 kg. Hospitalized children who are <12 years old or weigh <40 kg can receive remdesivir through an Emergency Use Authorization (EUA). Remdesivir is the first drug to be approved in the US for treatment of COVID-19.