Regeneron Pharmaceuticals and partner Sanofi announced that the Japanese Ministry of Health, Labour and Welfare has granted marketing and manufacturing authorization for Dupixent (dupilumab) to treat adults with moderate‑to‑severe bullous pemphigoid. The approval, effective March 24 2026, marks the first targeted medicine for this rare skin disease in Japan and expands Dupixent’s indication portfolio in a key market with a large unmet patient need.
The approval was based on the LIBERTY‑BP‑ADEPT Phase 2/3 study, which enrolled 106 adults with moderate‑to‑severe bullous pemphigoid. Patients receiving Dupixent 300 mg every two weeks achieved sustained disease remission in 18% of cases versus 4% for placebo at week 36. The study also reported a favorable safety profile, with treatment‑related adverse events in 26% of Dupixent patients compared to 15% of placebo patients; conjunctivitis was the most common treatment‑related adverse event, occurring in 4% of patients.
Dupixent is already approved in Japan for six other indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease. Bullous pemphigoid primarily affects elderly patients and has limited treatment options, many of which rely on systemic immunosuppression. The new approval provides a targeted, mechanism‑based therapy that addresses this unmet need.
The approval opens a new revenue stream for Regeneron and Sanofi. Regeneron’s Q4 2025 global Dupixent net sales increased 34% to $4.9 billion versus Q4 2024, and full‑year 2025 sales rose 26% to $17.8 billion. Sanofi reported Dupixent sales increased 32.2% year‑over‑year to €4.2 billion in Q4 2025. The addition of bullous pemphigoid strengthens Dupixent’s position as a leading IL‑4/IL‑13 dual‑blocker and supports the companies’ growth trajectory in the type‑2 inflammatory disease space.
Strategically, this approval is the seventh indication for Dupixent in Japan and the first targeted therapy for bullous pemphigoid. It expands the drug’s therapeutic reach and reinforces Regeneron’s and Sanofi’s commitment to developing targeted treatments for rare and underserved conditions.
The regulatory approval underscores the companies’ focus on unmet medical needs and positions Dupixent for continued growth in Japan and potentially other markets where bullous pemphigoid is prevalent.
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