Dupixent approved in Japan for moderate-to-severe bullous pemphigoid in adults
Japan's Ministry of Health, Labour and Welfare has approved Dupixent (dupilumab) for adults with moderate-to-severe bullous pemphigoid (BP), marking the first targeted therapy for the condition in the country.
Paris and Tarrytown, NY, March 24, 2026 – Japan's Ministry of Health, Labour and Welfare has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP). This approval marks the first targeted medicine available for BP patients in Japan.
The authorization is supported by data from the LIBERTY-BP-ADEPT Phase 2/3 study. The trial demonstrated that over four times more patients treated with Dupixent achieved sustained disease remission at Week 36 compared to those receiving placebo. Bullous pemphigoid is a chronic, relapsing skin disease characterized by intense itch, painful blisters, and lesions, associated with underlying type 2 inflammation.
With this approval, Dupixent now has seven indications in Japan. The drug is also approved for moderate-to-severe atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, chronic spontaneous urticaria, and COPD.
Bullous pemphigoid typically affects elderly patients and can lead to significant functional impairment and increased risk of infection. Previous treatment options were limited and could involve substantial systemic side effects, including immunosuppression.