FDA Approves Dupixent for Bullous Pemphigoid
By Lori Solomon HealthDay Reporter
Medically reviewed by Drugs.com
TUESDAY, June 24, 2025 -- The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid.
The approval is based on results from the pivotal ADEPT phase 2/3 study. Patients with moderate-to-severe bullous pemphigoid were randomly assigned to receive Dupixent 300 mg (53 individuals) or placebo (53 individuals) added to standard-of-care oral corticosteroids. At 36 weeks, 18.3 percent of patients treated with Dupixent experienced sustained disease remission versus 6.1 percent with placebo. Additionally, 38.3 percent of patients treated with Dupixent achieved clinically meaningful itch reduction versus 10.5 percent with placebo. Finally, median cumulative oral corticosteroid dose was lower with Dupixent versus placebo (2.8 versus 4.1 grams).
The most common adverse events (≥2 percent) observed in patients treated with Dupixent included arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis. One patient treated with Dupixent reported acute generalized exanthematous pustulosis.
"Until now, treating bullous pemphigoid was very challenging for elderly patients struggling with the debilitating impact of blisters and lesions, and potentially comorbid conditions," Alyssa Johnsen, M.D., Ph.D., global therapeutic area head for immunology and oncology development at Sanofi, said in a statement. "By addressing two central drivers of the underlying type 2 inflammation that contributes to bullous pemphigoid, Dupixent is the first targeted medicine to allow patients the potential to achieve sustained remission and reduce itch."
Approval of Dupixent for this indication was granted to Sanofi and Regeneron.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
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Posted June 2025
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