EMA accepts Dupixent filing for review

8 December 2016

The European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) for Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.

According to the drug’s developers, French pharma major Sanofi (Euronext: SAN) and partner US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN), the investigational biologic therapy Dupixent inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response, which is believed to be a major driver in the pathogenesis of the disease.

Blockbuster sales forecast

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