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 two new drugs for sickle cell disease: crizanlizumab-tmca (Adakveo – Novartis), an IV P-selectin blocker, and voxelotor (Oxbryta – GBT), an oral hemoglobin S (HbS) polymerization inhibitor.

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 loteprednol etabonate ophthalmic suspension 0.25% (Eysuvis – Kala) for short-term treatment (≤2 weeks) of dry eye disease. It is the first ocular corticosteroid to be approved for this indication. Other formulations of loteprednol are approved for treatment of steroid-responsive ocular inflammatory conditions, inflammation after ocular surgery, and seasonal allergic conjunctivitis.

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.

The FDA has approved Vtama (Dermavant), a 1% cream formulation of the aryl hydrocarbon receptor (AhR) agonist tapinarof, for treatment of adults with plaque psoriasis. It is the first AhR agonist to be approved by the FDA.

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The FDA has approved a 0.3% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of plaque psoriasis in patients ≥12 years old. Roflumilast is the first topical PDE4 inhibitor to be approved by the FDA for this indication; crisaborole (Eucrisa), another topical PDE4 inhibitor, is approved for treatment of atopic dermatitis. Oral roflumilast (Daliresp) is approved for treatment of chronic obstructive pulmonary disease.

The FDA has approved zavegepant nasal spray (Zavzpret – Pfizer) for acute treatment of migraine with or without aura in adults. Zavzpret is the first nasal spray formulation of a calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant") to become available in the US.

The FDA has approved a 0.3% foam formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of seborrheic dermatitis in patients ≥9 years old. Roflumilast is the first PDE4 inhibitor to be approved in the US for this indication. It is also available in a 0.3% cream formulation (Zoryve) for treatment of plaque psoriasis and in an oral formulation (Daliresp, and generics) for treatment of chronic obstructive pulmonary disease. A 0.15% cream formulation for treatment of atopic dermatitis in patients ≥6 years old will be reviewed...