FDA Grants Priority Review to Dupixent for Bullous Pemphigoid

Regeneron Pharmaceuticals and Sanofi have announced that the FDA has accepted Dupixent® (dupilumab) for Priority Review to treat bullous pemphigoid (BP), a rare and debilitating autoimmune skin disease. The supplemental Biologics License Application (sBLA) is backed by a pivotal clinical trial showing that Dupixent led to five times more sustained disease remission than placebo, with reduced disease severity, itching, and reliance on oral corticosteroids.

BP primarily affects elderly individuals, causing painful blisters, intense itching, and severe skin inflammation that can lead to infections and reduced mobility. With an estimated 27,000 adults in the U.S. struggling with BP uncontrolled by standard treatments, Dupixent could provide a much-needed alternative. The Priority Review status underscores the therapy’s potential to transform patient care, and if approved, it would be the first targeted treatment for BP in the U.S.