Sanofi has announced that 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 is based on the pivotal Phase 2/3 LIBERTY-BP-ADEPT study, which demonstrated that the number of Dupixent-treated patients achieving sustained disease remission through week 36 was more than four times higher than in the placebo group.
Treatment-emergent adverse events occurred in 26% of patients treated with Dupixent compared to 15% in the placebo group. The most frequently reported adverse event associated with Dupixent was conjunctivitis (4%).
A chronic and relapsing skin disease driven by underlying type 2 inflammation, BP is characterized by intense pruritus associated with painful blisters and other lesions. Available treatment options remain limited.
BP marks the seventh indication approved for Dupixent in Japan, following atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease.
Sanofi is the largest European pharmaceutical group. Net sales by family of products break down as follows:
- pharmaceutical products (81.8%): prescription drugs for the treatment of multiple sclerosis, neurological diseases, inflammatory diseases, autoimmune diseases, rare diseases, cancers and rare hematological diseases;
- human vaccines (18.2%): pediatric vaccines, vaccines for flu, meningitis, and polio, booster vaccines, and vaccines for travelers and endemic areas.
At the end of 2025, the group had 37 production sites worldwide.
Net sales are distributed geographically as follows: France (3.9%), Europe (17.1%), the United States (50.8%), China (6%) and other (22.2%).
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