Dupixent (dupilumab) filed in the EU for moderate-to-severe atopic dermatitis- Sanofi/Regeneron Pharma

Sanofi and Regeneron Pharmaceuticals announced that the European Medicines Agency (EMA) 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. The MAA for Dupixent contains data from three Phase III pivotal studies in the global LIBERTY AD program that included more than 2,500 patients. The objective of the studies was to evaluate Dupixent as monotherapy (SOLO 1 and SOLO 2) and in concomitant administration with topical corticosteroids (CHRONOS), in adult patients with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies.

Comment: A biologics license application (BLA) for Dupixent was accepted for Priority Review by the FDA in September 2016. Per the Prescription Drug User Fee Act, the target FDA action date is March 29, 2017. The European Medicines Agency (EMA) and FDA have conditionally accepted Dupixent as the trade name for dupilumab.