The US FDA has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, according to Regeneron Pharmaceuticals and Sanofi.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis, and eosinophilic esophagitis, the companies report.
The drug is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma aged 12 and older with elevated eosinophils or oral corticosteroid dependent asthma.
The sBLA is supported by data that include pivotal Phase 3 results evaluating the efficacy and safety of Dupixent in addition to standard-of-care maintenance therapy in children with moderate-to-severe asthma with type 2 inflammation, characterized by raised blood eosinophil levels and/or raised fractional exhaled nitric oxide (FeNO) levels, the companies report. According to trial data, Dupixent significantly reduced severe asthma attacks and rapidly improved lung function within two weeks in children aged 6 to 11 years. Safety results were generally consistent with the well-established safety profile of Dupixent in the approved indication for patients aged 12 and older with moderate-to-severe asthma. Adverse events in the Phase 3 trial that were more commonly observed with Dupixent included injection site reactions, viral upper respiratory tract infections and eosinophilia. Detailed results from this Phase 3 trial will be published later this year.
According to the companies, the target action date for the FDA decision is October 21, 2021 and the European Union (EU) regulatory submission for children aged 6 to 11 years with asthma is planned for Q1 2021.