U.S. FDA regulator gives new priority review for Sanofi and Regeneron's Dupixent

Send a link to a friend  Share

[January 28, 2020]  PARIS (Reuters) - The U.S. Food & Drug Administration (FDA) regulatory body has accepted for priority review the use of Sanofi and Regeneron's Dupixent product for children aged 6-11 with moderate-to-severe eczema, the companies said.

Sanofi and Regeneron added in a statement that if Dupixent won approval from the FDA, it would become the first biologic medicine available in the United States for such children.

The FDA is due to make its decision on May 26.

(Reporting by Sudip Kar-Gupta; Editing by Kim Coghill)

[ 2020 Thomson Reuters. All rights reserved.]

Copyright 2020 Reuters. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.

 

 

Back to top