- The sBLA is based on P-III study assessing Dupixent + SOC maintenance therapy in children aged 6-11yrs. with moderate-to-severe asthma with type 2 inflammation
- The study resulted in a reduction of severe asthma attacks and rapidly improved lung function within 2wks, safety results were generally consistent with the known safety profile of Dupixent.
- Dupixent is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma aged ≥12yrs. The anticipated PDUFA date is Oct 21, 2021, and the EU regulatory submission is planned for Q1’2021
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