FDA accepts Dupixent sBLA in children with asthma for review

The US Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on treatment for children aged six to 11 years with uncontrolled moderate-to-severe asthma.

Dupixent, which is marketed by France’s Sanofi (Euronext: SAN) and Regeneron (Nasdaq: REGN) and generated 3.5 billion euros ($4.2 billion) sales in 2020, up 73% on 2019, 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 target action date for the FDA decision is October 21, 2021 and the European Union regulatory submission for children aged 6 to 11 years with asthma is planned for first-quarter 2021.
The sBLA is supported by data that include pivotal Phase III 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 elevated blood eosinophil levels and/or raised fractional exhaled nitric oxide (FeNO) levels.