BioCentury
ARTICLE | Clinical News

Priority Review for Dupixent in adolescent atopic dermatitis

November 9, 2018 7:31 PM UTC

Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA accepted and granted Priority Review to an sBLA for Dupixent dupilumab to treat adolescents ages 12 to 17 with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical therapies. Its PDUFA date is March 11, 2019.

The human mAb targeting the α subunit of the IL-4 receptor (IL-4R; IL-4RA; CD124) and the IL-13 receptor is already approved in the U.S. to treat adults with moderate to severe atopic dermatitis not adequately controlled with topical therapies...