Posted by Michael Wonder on 04 Mar 2021
FDA accepts Dupixent (dupilumab) for review in children with moderate to severe asthma
4 March 2021 - Submission 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 randomised Phase 3 trial.
Regeneron Pharmaceuticals and Sanofi today announced that the U.S. FDA has accepted for review the supplemental biologics license application for Dupixent (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate to severe asthma.
The target action date for the FDA decision is 21 October 2021 and the European Union regulatory submission for children aged 6 to 11 years with asthma is planned for Q1 2021.
