Japan Approves Regeneron And Sanofi’s Dupixent For Bullous Pemphigoid Following Strong Phase 2/3 Remission Results

Regeneron Pharmaceuticals and Sanofi announced that Japan’s Ministry of Health, Labour and Welfare has approved Dupixent® (dupilumab) for adults with moderate-to-severe bullous pemphigoid, a rare and serious autoimmune skin disorder. The decision expands Dupixent’s immunology portfolio in Japan into another high-unmet-need dermatology indication.

The approval is supported by results from the pivotal LIBERTY-BP-ADEPT Phase 2/3 trial, which assessed Dupixent in combination with standard oral corticosteroids. In the study, patients receiving Dupixent were significantly more likely to achieve sustained disease remission than those given a placebo. At Week 36, remission rates were more than 4 times higher in the Dupixent group than in the placebo group, demonstrating a clinically meaningful benefit when added to standard therapy.

Safety findings were consistent with the drug’s known profile. Treatment-related adverse events were reported in about one-quarter of Dupixent-treated patients compared with 15% in the placebo group, with conjunctivitis being the most commonly observed side effect. Beyond bullous pemphigoid, Dupixent is already approved in Japan for several inflammatory conditions, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease.