The FDA has accepted for review the supplemental Biologics License Application (sBLA) of Dupilumab (trade name Dupixent) as an add-on maintenance treatment in patients 12 and older with moderate to severe asthma. A decision is expected by October 20, 2018, according to a press release from manufacturers Regeneron Pharmaceuticals and Sanofi.
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 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 the Phase 3 QUEST and VENTURE trials will be submitted for presentation at medical meetings later this year.
The potential use of Dupixent in asthma is currently under clinical development and the safety and efficacy for this use have not been fully evaluated by any regulatory authority.
In March 2017, the FDA approved Dupixent in the US for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Dupixent is also approved for use in certain patients with moderate-to-severe atopic dermatitis in a number of other countries, including the countries of the European Union, Canada, and Japan.