Officials with the FDA have granted Priority Review to the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent, Regeneron and Sanofi) as an add-on maintenance treatment for children ages 6 to 11 years with moderate-to-severe atopic dermatitis (AD), according to a press release.
If approved for this indication, dupilumab would serve as an option for children whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Dupilumab is a fully human monoclonal antibody that works to inhibit the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins Previous studies have shown that IL-14 and IL-13 are key drivers of the type 2 inflammation that plays a major role in AD, asthma, and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Moderate-to-severe AD can cause uncontrolled, persistent symptoms including intense itching, skin lesions and skin dryness, cracking, redness or darkness, crusting, and oozing. Despite treatment with standard-of-care therapy, individuals with AD may experience significant disease burden.
Submission of this sBLA is based on data from the phase 3 clinical study which evaluated the efficacy and safety of dupilumab combined with topical corticosteroids (TSC) in children with severe AD.
According to the results, children who received dupilumab plus TSC demonstrated significantly improved measures of overall disease severity, skin clearing, itching, and health-related quality of life compared with TCS alone.
Adverse effects most commonly reported in the study with dupilumab and TCS included conjunctivitis, nasopharyngitis, and injection site reactions, which is consistent with the known safety profile of dupilumab in older patients, according to Regeneron.
Dupilumab is currently approved to treat patients aged 12 years and older with moderate-to-severe AD that is not well controlled with topical prescription therapies or who cannot use topical therapies. It is also indicated for use with other asthma medications as a 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 medications, as well as for use with other medicines to treat CRSwNP in adults whose disease is not controlled.
The target action date for the FDA decision on this sBLA is May 26, 2020.
- FDA accepts for Priority Review Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis [news release]. Regeneron’s website. https://investor.regeneron.com/news-releases/news-release-details/fda-accepts-priority-review-dupixentr-dupilumab-children-aged-6. Accessed January 28, 2020.