Posted by Michael Wonder on 03 Apr 2018
EMA to review Dupixent (dupilumab) as potential treatment for inadequately controlled moderate-to-severe asthma
3 April 2018 - The EMA has accepted for review an application for Dupixent (dupilumab) as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with inadequately controlled moderate-to-severe asthma.
Dupixent is a human monoclonal antibody specifically designed to inhibit signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two important signaling proteins (cytokines) that contribute to Type 2 inflammation in inadequately controlled moderate-to-severe asthma.
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 two of these trials, the Phase 3 QUEST and VENTURE trials, will be presented at the American Thoracic Society 2018 International Conference in May.
