PARIS Dec 8 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
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)