FDA Approves Dupilumab for Bullous Pemphigoid

Dupilumab has been approved by the FDA for the treatment bullous pemphigoid in adults, the manufacturer Regeneron announced.

Dupilumab (Dupixent), a human monoclonal antibody that inhibits interleukin (IL)-4 and IL-13 signaling, is now approved in the United States for eight diseases, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis. Dupilumab, administered by subcutaneous injection, is the first targeted treatment to be approved in the United States for bullous pemphigoid, according to the company’s press release.

The approval follows a supplemental New Drug Application filed with the FDA in February 2025 and is based on data from ADEPT, a pivotal phase 2/3 study in more than 100 adults with moderate-to-severe bullous pemphigoid, according to Regeneron. The study’s design was published in Advances in Therapy.

In the study, 106 patients were randomized to 300 mg of subcutaneous dupilumab or a placebo injection every 2 weeks, added to standard-of-care oral corticosteroids. At 36 weeks, 18.3% of patients in the dupilumab group achieved the primary endpoint of sustained disease remission compared with 6.1% of those in the placebo group. The study defined sustained remission as a combination of complete clinical remission and no relapse after an oral corticosteroid taper by 16 weeks, with no use of rescue therapy during the study period. 

More patients treated with dupilumab achieved a clinically meaningful reduction in itching (38.3% vs 10.5%), and the median cumulative oral corticosteroid dose in the dupilumab-treated group was 2.8 g vs 4.1 g in the placebo group, according to the company release.

The most common adverse events among patients receiving dupilumab (affecting 2% or more) compared with those receiving placebo were arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis. One patient receiving dupilumab also developed acute generalized exanthematous pustulosis; no cases were reported among those receiving placebo. 

The dupilumab study was funded by Sanofi and Regeneron, the companies co-developing dupilumab.