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.
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