PARIS, Dec 8 (Reuters) - The European Medicines Agency (EMA), the European Union’s health regulator, has accepted for review the Dupixent product being developed by drugmakers Sanofi and Regeneron, the companies said on Thursday.
Dupixent is aimed at adults with eczema or moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy.
A biologics license application (BLA) for Dupixent was accepted for Priority Review by the U.S. Food and Drug Administration (FDA) in September 2016.
As per the U.S. Prescription Drug User Fee Act (PDUFA), the target FDA action date is March 29, 2017. The EMA and FDA have conditionally accepted Dupixent as the trade name for dupilumab. (Reporting by Sudip Kar-Gupta; Editing by Amrutha Gayathri)