FDA Accepts Dupixent sBLA for Bullous Pemphigoid Treatment

The FDA has accepted a supplemental Biologics License Application (sBLA) for Regeneron and Sanofi's Dupixent (dupilumab) to treat bullous pemphigoid (BP), a severe autoimmune skin disorder, with a decision expected by June 20, 2025. If approved, Dupixent would be the first targeted therapy for BP in the U.S., which currently lacks any FDA-approved treatments. The application received Priority Review due to positive results from a pivotal phase 3 clinical study, where Dupixent demonstrated a fivefold improvement in sustained disease remission compared to placebo. However, safety concerns arise from reported adverse events that occurred more frequently in patients receiving Dupixent. The drug is already established in treating other conditions linked to type 2 inflammation, and its potential approval could address a significant unmet medical need for approximately 27,000 U.S. adults suffering from uncontrolled BP. The approval may position Dupixent uniquely in a market currently reliant on corticosteroids, which have notable side effects.