FDA Approves Dupixent for Bullous Pemphigoid Treatment

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for treating adult patients with bullous pemphigoid (BP). This condition primarily affects the elderly and is marked by intense itching, painful blisters, and skin lesions. Dupixent becomes the only targeted treatment option for BP in the US, offering hopes for sustained remission and reduced symptoms.

BP, a rare and debilitating skin disease, affects approximately 27,000 adults in the US who do not respond well to systemic corticosteroids. Dupixent's approval relies on pivotal results from the ADEPT phase 2/3 study, which showed significant improvements over placebo. The drug demonstrated reductions in itch, lower steroid usage, and allowed some patients to achieve sustained disease remission.