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Sanofi : FDA Accepts Dupixent For Review In Children With Moderate-to-severe Asthma

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi said that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application or sBLA for Dupixent or dupilumab as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.

The submission was supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial.

The companies noted that the acceptance represents another milestone in the development of Dupixent in addressing diseases driven by type 2 inflammation.

Dupixent 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 the first-quarter 2021.

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