Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) announced that Japan's Ministry of Health, Labour and Welfare has approved Dupixent (dupilumab) for adults with moderate-to-severe bullous pemphigoid, making it the first targeted therapy available for this rare and debilitating skin disease.
Bullous pemphigoid is characterized by painful blisters, severe itching, and lesions that can significantly affect quality of life, and current treatment options largely rely on long-term use of oral corticosteroids and immunosuppressants.
The approval is supported by data from the LIBERTY-BP-ADEPT Phase 2/3 trial, which showed that patients receiving Dupixent were more than four times as likely to achieve sustained disease remission compared to placebo.
Importantly, Dupixent also allowed patients to taper off steroids earlier, reducing dependence on board immunosuppressive therapy. Safety results were consistent with Dupixent's established profile, with conjunctivitis being the most common adverse event.
This marks the seventh approved indication for Dupixent in Japan, where it is already authorized for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease. Globally, Dupixent has become a cornerstone therapy for type 2 inflammatory diseases, with more than 1.4 million patients treated across multiple conditions.
Dupixent continues to be Sanofi's key growth driver generating €15.7 billion in global sales in 2025, a 25% increase from €13.1 billion in 2024. The United States accounted for the majority, contributing €11.5 billion, up 26% from €9.5 billion, in 2024.
SNY has traded between $43.32 and $56.93 over the past year. The stock closed Monday's trading at $44.77, up 0.38%. In the pre-market trading the stock is up at $45.05, up 0.63%.
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