Sanofi and Regeneron Pharmaceuticals Inc. said the U.S. Food and Drug Administration will review Dupixent as an add-on maintenance treatment for some patients suffering from moderate-to-severe asthma.
The regulator accepted the supplemental biologics license application for Dupixent, or dupilumab, to review its use in this new disease area. The application is supported by trial data from the Liberty Asthma program, which enrolled 2,888 adults and adolescents.
A response from the FDA is expected Oct. 20.
The treatment is already approved in the U.S. and in some other countries for treating patients suffering from moderate-to-severe atopic dermatitis, or eczema — a type of skin disease.
Dupixent is an antibody designed to inhibit two proteins that cause inflammation in people with moderate-to-severe asthma. Asthma, which affects more than 24 million people in the U.S., is caused by inflammations in a patient's airways, resulting in chest tightness, shortness of breath and coughing.
The French drugmaker and New York-based Regeneron are jointly developing dupilumab to treat a range inflammation-driven diseases, including pediatric atopic dermatitis, and nasal polyps.
