Sanofi and Regeneron Receive FDA Approval for Dupixent in Bullous Pemphigoid

Sanofi and Regeneron today announced that the FDA has approved Dupixent (dupilumab) for the treatment of adults with bullous pemphigoid (BP). BP is a rare, autoimmune blistering skin disease that primarily affects older adults. In the Phase 3 ADEPT trial, Dupixent demonstrated a statistically significant improvement in the proportion of patients achieving complete remission compared to placebo. Dupixent targets the IL-4 and IL-13 pathways, which are central to the type 2 inflammation underlying BP. This approval expands Dupixent's growing portfolio of approved indications into another rare skin disease.