Japan’s Ministry of Health, Labour and Welfare has approved Dupixent (dupilumab) for treating adults with moderate-to-severe bullous pemphigoid, marking the seventh indication for the drug in Japan. The approval is based on the Phase 2/3 LIBERTY-BP-ADEPT trial, which showed more than four times as many patients on Dupixent achieved sustained disease remission compared to placebo at week 36, with rates of 18% versus 4%.
Bullous pemphigoid is a chronic, relapsing skin condition characterized by intense itching, painful blisters, and lesions that primarily affects elderly patients. The study involved 106 adults receiving either Dupixent 300 mg or placebo alongside standard oral corticosteroids. Treatment-related adverse events occurred in 26% of Dupixent patients versus 15% on placebo, with conjunctivitis as the most commonly reported side effect.
In Japan, Dupixent is now approved across seven indications including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, chronic spontaneous urticaria, and COPD. The drug is developed jointly by Sanofi and Regeneron Pharmaceuticals.