The FINANCIAL -- The European Medicines Agency (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, according to Sanofi.
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.
In addition, the U.S. Food and Drug Administration is reviewing a supplemental Biologics License Application for Dupixent as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-severe asthma, with a target action date of October 20, 2018.
Dupixent is currently approved in the European Union for use in adults with moderate-to-severe atopic dermatitis (eczema) who are candidates for systemic therapy. Dupixent is approved in the U.S. for the treatment of adults with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), 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 Canada, Japan and Australia.
The potential use of Dupixent for the treatment of adults and adolescents (12 years of age and older) with inadequately controlled moderate-to-severe asthma is currently under regulatory review and the safety and efficacy for this use have not been fully evaluated by any regulatory authority.