FDA accepts for priority review Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis
*If approved, Dupixent would be the first biologic medicine available in the U.S. for these children
PARIS and TARRYTOWN, NY – January 28, 2020 - The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The target action date for the FDA decision is May 26, 2020.
Despite standard-of-care therapy, many young children with moderate-to-severe atopic dermatitis continue to experience uncontrolled, persistent symptoms. These children live with intense, persistent itching, skin lesions and skin dryness, cracking, redness or darkness, crusting and oozing. Beyond the physical symptoms, moderate-to-severe atopic dermatitis can have a significant impact on health-related quality of life for children, as well as placing a burden on their families.
The sBLA is supported by data that includes pivotal Phase 3 results on the efficacy and safety of Dupixent combined with topical corticosteroids (TCS) in children with severe atopic dermatitis. In the trial, children treated with Dupixent and TCS experienced significantly improved measures of overall disease severity, skin clearing, itching and health-related quality of life, compared to TCS alone. Adverse events that were more commonly observed with Dupixent included conjunctivitis, nasopharyngitis and injection site reactions, which is consistent with the previously documented safety profile of Dupixent in older populations. Detailed results from this trial will be presented at an upcoming medical congress.
In 2016, the FDA granted Breakthrough Therapy designation to review Dupixent for the treatment of severe atopic dermatitis in children 6 months to 11 years of age not well controlled on topical prescription medications.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Dupixent is approved in the U.S. to treat patients aged 12 years and older with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies; for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older whose asthma is not controlled with their current asthma medicines; and for use with other medicines to treat CRSwNP in adults whose disease is not controlled.
Outside of the U.S., Dupixent is approved for specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma in a number of other countries around the world, including the EU and Japan. Dupixent is also approved in the EU to treat certain adults with severe CRSwNP.
Dupilumab Development Program
To date, there have been 11 pivotal studies involving more than 9,000 patients across various chronic type 2 inflammatory diseases.
In addition to the currently approved indications, Sanofi and Regeneron are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other type 2 inflammation, including pediatric asthma (6 to 11 years of age, Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 2/3), eosinophilic esophagitis (Phase 3), chronic obstructive pulmonary disease (Phase 3) and food and environmental allergies (Phase 2). Dupilumab is also being studied in combination with SAR440340 (REGN3500), which targets IL-33. 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.