Posted by Michael Wonder on 02 Mar 2018
FDA to review Dupixent (dupilumab) as potential treatment for moderate-to-severe asthma
2 March 2018 - The U.S. FDA has accepted for review the supplemental biologics license application of Dupixent (dupilumab) as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-severe asthma.
Per the Prescription Drug User Fee Act, the target action date is 20 October 2018.
The application is supported by clinical data from 2,888 adults and adolescents who participated in three pivotal trials from the LIBERTY ASTHMA clinical development program. Detailed results from the Phase 3 QUEST and VENTURE trials will be submitted for presentation at medical meetings later this year.
