Dupixent, a biologic developed by Sanofi (SNY.US) and Regeneron (REGN.US), has been granted priority review by the FDA, which could make it the first targeted therapy approved in the U.S. for BP.

On February 18, Sanofi (SNY.US) and Regeneron (REGN.US) jointly announced that the FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent for the treatment of adult bullous pemphigoid (BP). The PDUFA date is June 20, 2025. If approved, Dupixent will become the first and only targeted therapy for BP in the United States. BP is a chronic, debilitating, and recurrent skin disease with potential 2T inflammation, typically affecting older populations. It is characterized by intense itching, blisters, skin redness, and pain. Blisters and rashes can form on most parts of the body and cause skin bleeding and scabbing, making patients more susceptible to infections and affecting their daily functions. In September 2024, Dupixent's ADEPT study for BP achieved success. This was a 52-week, randomized, double-blind, placebo-controlled clinical trial (n=106) evaluating the efficacy and safety of Dupixent (300mg every 2 weeks) in combination with oral corticosteroids (OCS) versus placebo in combination with OCS in patients with moderate to severe adult BP. The primary endpoint was the proportion of patients who achieved disease remission at week 36.