Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for the Targeted Treatment of Bullous Pemphigoid (BP)

Core Viewpoint - Dupixent (dupilumab) is under Priority Review by the FDA for the treatment of bullous pemphigoid (BP), with a decision expected by June 20, 2025, potentially making it the first targeted therapy for BP in the U.S. [1][5] Group 1: Drug Efficacy and Clinical Trials - The supplemental Biologics License Application (sBLA) for Dupixent is supported by a pivotal trial involving 106 adults with moderate-to-severe BP, where Dupixent patients achieved sustained disease remission five times more than those on placebo [2] - Sustained disease remission was defined as complete clinical remission with the tapering of oral corticosteroids by week 16, without relapse or rescue therapy during the 36-week treatment period [2] - The trial demonstrated significant reductions in disease severity, itch, and the use of oral corticosteroids compared to placebo [2] Group 2: Disease Background and Patient Population - Bullous pemphigoid is a chronic, debilitating skin disease characterized by intense itching, blisters, and painful lesions, primarily affecting an elderly population [4] - Approximately 27,000 adults in the U.S. suffer from uncontrolled BP despite systemic corticosteroid treatment [4] Group 3: Regulatory Status and Designations - Dupixent has been granted Priority Review by the FDA, which is reserved for therapies that show potential for significant improvements in treating serious conditions [5] - The drug previously received Orphan Drug Designation for BP, indicating its intended use for a rare disease affecting fewer than 200,000 people in the U.S. [5] Group 4: Safety Profile - Common adverse events associated with Dupixent include peripheral edema, arthralgia, back pain, and upper respiratory tract infections, among others [3]