The FDA has approved benralizumab (Fasenra – AstraZeneca), a humanized monoclonal antibody selective for the interleukin-5 (IL-5) receptor, for add-on maintenance treatment of severe asthma in patients ≥12 years old with an eosinophilic phenotype. Benralizumab is the third anti-IL-5 antibody to be approved for treatment of severe eosinophilic asthma; mepolizumab (Nucala) and reslizumab (Cinqair), which target IL-5 itself, were approved earlier.

The FDA has approved the fixed-dose combination of tezacaftor and ivacaftor (Symdeko – Vertex) for oral treatment of cystic fibrosis (CF) in patients ≥12 years old who are homozygous for the F508del (also called Phe508del or ΔF508) mutation or have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the combination. About 50% of CF patients in the US are homozygous for the F508del mutation. This is the first approved indication for tezacaftor. Ivacaftor is also available in combination with lumacaftor...

The FDA has approved a sublingual tablet (Nocdurna – Ferring) and a nasal spray (Noctiva – Avadel) formulation of desmopressin acetate for treatment of nocturia due to nocturnal polyuria in adults who wake up ≥2 times per night to void. Nocdurna and Noctiva are the first two products to be approved in the US for this indication. Higher-strength nasal spray and oral tablet formulations of desmopressin (DDAVP, and others) have been available for years for treatment of diabetes insipidus and primary nocturnal enuresis (bedwetting in children). In 2007, the indication for primary...

The FDA has approved solriamfetol (Sunosi – Jazz), a dopamine and norepinephrine reuptake inhibitor (DNRI), to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA). Pitolisant (Wakix), an H3-receptor antagonist/inverse agonist recently approved by the FDA for treatment of excessive daytime sleepiness in patients with narcolepsy, will be reviewed in a future issue.

The FDA has approved Dovato (ViiV), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay) and the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, and generics), as a once-daily complete regimen for treatment of adults with HIV-1 infection who are antiretroviral-treatment naive and have no known substitutions associated with resistance to either drug. Dolutegravir/lamivudine is the first complete regimen to be approved by the FDA for initial treatment of HIV-1 infection that contains 2 rather than 3 antiretroviral...

The FDA has approved trifarotene 0.005% cream (Aklief – Galderma) for topical treatment of acne vulgaris in patients ≥9 years old. Trifarotene is the fourth topical retinoid to be approved in the US for treatment of acne; tretinoin (Retin-A, and others), adapalene (Differin, and generics), and tazarotene (Tazorac, and others) have been available by prescription for decades. Adapalene 0.1% gel has been available over the counter since 2016 for treatment of acne in patients ≥12 years old.

The FDA has approved an orally disintegrating tablet (ODT) formulation of rimegepant (Nurtec ODT – Biohaven), a small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant"), for acute treatment of migraine with or without aura in adults. Rimegepant is the second oral gepant to become available in the US; ubrogepant (Ubrelvy), which is approved for the same indication, was the first. Four parenteral CGRP antagonists, erenumab (Aimovig), fremanezumab (Ajovy), galcanezumab (Emgality), and eptinezumab (Vyepti), are approved for prevention of...

The FDA has approved cenobamate (Xcopri – SK Life Science) for oral treatment of partial-onset (focal) seizures in adults.

Oliceridine (Olinvyk - Trevena), an IV opioid agonist, has been approved by the FDA for management of acute pain severe enough to require an opioid and for which alternative treatment options are inadequate.

The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has received an Emergency Use Authorization (EUA) from the FDA for IV treatment of COVID-19 in hospitalized patients ≥2 years old who are receiving a systemic corticosteroid and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Tocilizumab has been approved by the FDA for various indications, including rheumatoid arthritis and juvenile idiopathic arthritis.