The United States Food and Drug Administration (FDA) has accepted for review France-based Sanofi's supplemental biologics license application of Dupixent (dupilumab) as an add-on maintenance treatment for certain adults and adolescents having moderate-to-severe asthma, it was reported yesterday.
The target action date is 20 October 2018 as per the Prescription Drug User Fee Act.
The product is a human monoclonal antibody specifically designed to inhibit signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two important signalling proteins (cytokines) that contribute to Type 2 inflammation in moderate-to-severe asthma. 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 3 QUEST and VENTURE trials will be submitted for presentation at medical meetings later this year.
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