Bullous pemphigoid first biologic FDA approval with autoimmune blistering skin disease treatment
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Sanofi and Regeneron Receive FDA Approval for Dupixent in Bullous Pemphigoid

Sanofi and Regeneron announce FDA approval of dupilumab (Dupixent) for adults with bullous pemphigoid, the first biologic approved for this rare skin disease.

Sanofi and Regeneron today announced that the FDA has approved Dupixent (dupilumab) for the treatment of adults with bullous pemphigoid (BP). This marks the first biologic therapy approved for BP, a rare autoimmune blistering skin disease. In the Phase 3 ADHERE BP trial, Dupixent demonstrated a significantly higher sustained disease control rate compared to placebo. Dupixent inhibits IL-4 and IL-13 signaling, key drivers of type 2 inflammation in BP. This approval provides patients with a new targeted treatment option for this debilitating condition.

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