FDA to evaluate sBLA of DUPIXENT for Asthama patients

Regeneron Pharmaceuticals and Sanofi claimed that the U.S Food and Drug Administration has considered to assess the supplemental Biologics License Application (sBLA) of DUPIXENT as an add-on-maintenance treatment in certain adults and adolescents (12 years of age or older) inflicted with moderate-to severe asthama.

According to the Prescription Drug User Fee Act, the target action date is October 20, 2018.

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 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.

FDA approved DUPIXENT in the U.S. 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 sanctioned 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.

People who live with moderate-to-severe asthma often experience decreased lung function and have severe attacks (exacerbations) that may lead to emergency room visits and hospitalizations. Despite currently available treatments, there remains an unmet need in patients who suffer from decreased lung function, severe exacerbations, long-term oral corticosteroid use and poor quality of life. Moderate-to-severe asthma is often associated with other Type 2 allergic inflammatory diseases.