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# Dupixent sBLA for Pediatric Asthma
- URL: https://www.fdaweb.com/dupixent-sbla-for-pediatric-asthma/
- Published: 2021-03-04T12:00:00.000Z
- Updated: 2026-09-14T16:49:29.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148810

FDA has accepted for review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. 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 user fee review action target action date is 10/21.

The submission is supported by data that include pivotal [Phase 3 results](https://c212.net/c/link/?t=0&l=en&o=3086376-1&h=1799575632&u=https%3A%2F%2Fnewsroom.regeneron.com%2Fnews-releases%2Fnews-release-details%2Fdupixentr-dupilumab-significantly-reduced-severe-asthma-attacks&a=Phase+3+results&ref=fdaweb.com) evaluating the efficacy and safety of Dupixent in addition to standard-of-care maintenance therapy in children with moderate-to-severe asthma with Type 2 inflammation, characterized by raised blood eosinophil levels and/or raised fractional exhaled nitric oxide levels, according to the companies. In the trial, Dupixent significantly reduced severe asthma attacks and rapidly improved lung function within two weeks in children aged 6 to 11 years. Safety results were generally consistent with the drug’s established safety profile and included injection site reactions, viral upper respiratory tract infections and eosinophilia.