By Fineline Cube 
Sanofi (EPA: SAN, NASDAQ: SNY) announced that the US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Dupixent (dupilumab) for the treatment of adults with bullous pemphigoid (BP) and granted it priority review status. The FDA is expected to make its decision by June 20, 2025, potentially making Dupixent the first and only therapy for BP in the US.
About Bullous Pemphigoid
BP is a chronic, debilitating, and relapsing skin disease characterized by intense itching, blisters, skin redness, and painful lesions. It typically occurs in the elderly population and is driven by underlying type-2 inflammation.
Drug Profile
Dupixent is a fully human monoclonal antibody that inhibits the signaling of interleukin-4 (IL4) and interleukin-13 (IL13) pathways. It is approved in over 60 countries for conditions including atopic dermatitis, asthma, chronic spontaneous urticaria, and chronic obstructive pulmonary disease.
Clinical Trial Results
The sBLA is supported by a pivotal study involving 106 adults with moderate-to-severe BP. The trial met its primary endpoint, with five times more patients achieving sustained disease remission on Dupixent compared to placebo. The drug also significantly reduced disease severity, itching, and the use of oral corticosteroids (OCS).-Fineline Info & Tech