Articol

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

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

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, Reuters reported.

 

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.

Comentarii