FDA reviewing marketing application for Dupixent in moderate-to-severe asthma.- Regeneron Pharma + Sanofi.

The FDA has accepted for review the supplemental Biologics License Application (sBLA) of Dupixent (dupilumab), from Regeneron Pharma and Sanofi, as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-severe asthma. Per the Prescription Drug User Fee Act, the target action date is October 20, 2018.

The application is supported by clinical data from 2,888 adults and adolescents who participated in three pivotal trials from the LIBERTY ASTHMA clinical development program. Detailed results from the Phase III QUEST and VENTURE trials will be submitted for presentation at medical meetings later this year.

Comment: Sanofi and Regeneron are studying dupilumab in a broad range of clinical development programs for diseases driven by Type 2 inflammation, including pediatric atopic dermatitis (Phase III), nasal polyps (Phase III) and eosinophilic esophagitis (Phase II). These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority. Dupilumab was discovered using Regeneron's proprietary VelocImmune technology that yields optimized fully-human antibodies, and is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.