Posted by Michael Wonder on 26 Sep 2016
Sanofi and Regeneron announce dupilumab biologics license application accepted for priority review by U.S. FDA
26 September 2016 - Sanofi and Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for priority review the biologics license application for dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD), a serious, chronic inflammatory skin disease.
The application has been given a Prescription Drug User Fee Act target action date of March 29, 2017. The investigational biologic therapy dupilumab inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response, which is believed to be major driver in the pathogenesis of the disease.
