Priority review for Sanofi and Regeneron's dupilumab

The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) for dupilumab, a treatment for adults with inadequately controlled moderate-to-severe atopic dermatitis (AD), a serious, chronic inflammatory skin disease.

Sanofi Genzyme, the specialty care global business unit of French pharma major Sanofi (Euronext: SAN), and US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN), will commercialize the drug if it does go on to receive approval, and the FDA has given the application a Prescription Drug User Fee Act (PDUFA) target action date of March 29 next year.

Dupilumab is an investigational biologic therapy that inhibits signaling of interleukin ( IL)-4 and IL-13, two key cytokines required for the type 2 immune response, which is believed to be a major driver in the pathogenesis of the disease.