Dupilumab marketing application under review in Europe

|By:, SA News Editor

Regeneron Pharmaceuticals (NASDAQ:REGN) and development partner Sanofi (NYSE:SNY) announce that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) seeking approval of Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.

The U.S. marketing application is currently under FDA review with an action date of March 29, 2017.

Dupilumab, a fully human monoclonal antibody, works by binding to (inhibiting) interleukin-4 (IL-4) and interleukin-13 (IL-13), two cytokines that play key roles in the pathogenesis of AD.

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