Bullous pemphigoid biologic FDA approval with IL-4 IL-13 inhibitor autoimmune skin disease treatment

RegulatoryJune 22, 2025Business Wire

Regeneron and Sanofi Receive FDA Approval for Dupixent in Bullous Pemphigoid

Regeneron and Sanofi announce FDA approval of dupilumab (Dupixent) for adults with bullous pemphigoid, expanding its rare skin disease indications.

Regeneron and Sanofi today announced that the FDA has approved Dupixent (dupilumab) for the treatment of adults with bullous pemphigoid (BP). In the Phase 3 ADHERE BP trial, Dupixent demonstrated a significantly higher sustained disease control rate compared to placebo. This approval makes Dupixent the first biologic approved for BP and expands its growing portfolio of skin disease indications. Dupixent inhibits IL-4 and IL-13 signaling, key drivers of type 2 inflammation in BP.

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