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Sanofi:FDA Reviews DUPIXENT As Potential Treatment For Moderate-to-Severe Asthma

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi said that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application
or sBLA of DUPIXENT or dupilumab 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.

DUPIXENT is a human monoclonal antibody specifically designed to inhibit signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two important signaling 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.

The potential use of DUPIXENT in asthma is currently under clinical development and the safety and efficacy for this use have not been fully evaluated by any regulatory authority.

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