Sanofi: Dupixent Gains Major New Approval in Japan
Dupixent (dupilumab), jointly developed by Sanofi and Regeneron, has been approved in Japan for the treatment of moderate to severe bullous pemphigoid in adults. This approval extends the therapeutic portfolio of the drug, which is already approved in over 60 countries for various indications.
Approval by the Japanese Ministry of Health, Labor and Welfare
The Japanese Ministry of Health, Labor and Welfare has granted manufacturing and marketing authorization for Dupixent to treat adults with moderate to severe bullous pemphigoid (BP). The approval is based on the results of the pivotal Phase 2/3 LIBERTY-BP-ADEPT study, which evaluated the drug in 106 randomized patients to receive Dupixent 300 mg or a placebo in combination with standard oral corticosteroid therapy. At the 36-week evaluation, 18% of patients treated with Dupixent achieved sustained disease remission, compared to 4% in the placebo group. Treatment-related adverse events occurred in 26% of patients treated with Dupixent and 15% of placebo patients, with conjunctivitis being the most frequently reported adverse effect with Dupixent (4%).
Expanded Approval in Japan
In Japan, Dupixent is now approved to treat certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), nodular prurigo, chronic spontaneous urticaria (CSU), chronic obstructive pulmonary disease (COPD), and bullous pemphigoid. Globally, the drug has received regulatory approvals in over 60 countries for one or more indications, with more than 1.4 million patients currently being treated with Dupixent. Sanofi and Regeneron continue the clinical evaluation of dupilumab in several other indications associated with type 2 inflammation.
