Paris and Tarrytown, NY – April 3, 2018 – 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.
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.
About Inadequately Controlled Moderate-to-Severe Asthma
People who live with inadequately controlled moderate-to-severe asthma often experience decreased ability to breathe (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 ability to breathe, severe attacks, long-term oral corticosteroid use and poor quality of life. Inadequately controlled moderate-to-severe asthma is often associated with other Type 2 inflammatory diseases. The disease is characterized by an imbalance or overactivity of certain immune cells and signaling proteins (including IL-4 and IL-13).
Dupilumab Development Program
Sanofi and Regeneron are studying dupilumab in a broad range of clinical development programs for diseases driven by Type 2 inflammation, including pediatric atopic dermatitis (Phase 3), nasal polyps (Phase 3) and eosinophilic esophagitis (Phase 2). These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
For more information on dupilumab clinical trials please visit www.clinicaltrials.gov.
About Regeneron Pharmaceuticals, Inc
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.