Press Release: Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid

Core Insights - The FDA has accepted the supplemental biologics license application (sBLA) for Dupixent (dupilumab) for the treatment of bullous pemphigoid (BP) under priority review [1][5][10] - Dupixent has shown significant efficacy in a pivotal study, with five times more patients achieving sustained disease remission compared to placebo [2][10] - BP is a chronic skin disease affecting approximately 27,000 adults in the US, characterized by severe itching and blisters [4][10] Group 1: Dupixent's Efficacy and Safety - The pivotal study involved 106 adults with moderate-to-severe BP, meeting its primary endpoint [2] - Dupixent significantly reduced disease severity, itch, and the use of oral corticosteroids compared to placebo [2] - Common adverse events associated with Dupixent included peripheral edema, arthralgia, and hypertension [3] Group 2: Regulatory and Market Context - Priority review is granted for therapies that may offer significant improvements in treating serious conditions [5] - Dupixent has received orphan drug designation for BP, indicating its potential impact on a rare disease affecting fewer than 200,000 people in the US [5] - If approved, Dupixent would be the first targeted treatment for BP in the US, with an FDA decision expected by June 20, 2025 [10] Group 3: Dupixent Development and Applications - Dupixent is a fully human monoclonal antibody targeting interleukin-4 and interleukin-13 pathways, not classified as an immunosuppressant [7] - The drug has received regulatory approvals in over 60 countries for various indications, with more than one million patients treated globally [8] - Dupilumab is being developed by Sanofi and Regeneron, with ongoing studies for additional diseases driven by type-2 inflammation [9][10]