FDA grants priority review to Dupixent for expanded label

Jan. 28, 2020

Sanofi and Regeneron’s eczema treatment has been granted priority review by the FDA for an expanded patient population.

The monoclonal antibody has already won FDA approval for moderate-to-severe eczema for patients over the age of 12. The priority review will be to now consider approval for children aged 6-11.

According to the companies, if Dupixent wins approval for the younger patient population, it will be the first biologic medicine available in the U.S. for that age group. 

The FDA is expected to make a final decision on May 26.

Read the Reuters report.