Sanofi's and Regeneron's Dupixent wins new stage of EU regulatory approval
PARIS (Reuters) - Healthcare companies Sanofi and Regeneron said on Friday the European Union's medicines regulator had given a new stage of approval for their Dupixent product to treat children as young as 6 months old with severe atopic dermatitis.
The European Commission is expected to announce a final decision on the Dupixent application in coming months. Dupixent was approved in June 2022 by the U.S. Food and Drug Administration (FDA) regulator for children in this age group.
The use of Dupixent in infants and young children less than 6 years of age suffering from severe atopic dermatitis is at an investigational stage for now in the EU, pending final approval.
In October, Sanofi had forecast faster earnings growth due to strong demand for its bestselling drug Dupixent and for its flu vaccines.
(Reporting by Sudip Kar-Gupta; Editing by Jacqueline Wong and Tom Hogue)