Shots:

• 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

 ­ Ref: Regeneron | Image: Foursquare