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# Priority Review for Dupixent sBLA
- URL: https://www.fdaweb.com/priority-review-for-dupixent-sbla/
- Published: 2022-02-10T12:00:00.000Z
- Updated: 2026-09-14T17:32:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151136

FDA has accepted for priority review a Sanofi sBLA for Dupixent (dupilumab) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The company [says](https://www.sanofi.com/en/media-room/press-releases/2022/2022-02-10-07-00-00-2382407?ref=fdaweb.com) the PDUFA target action date for the sBLA is 6/9\. Dupixent remains the only biologic medicine approved for patients age 6 and older in this indication, Sanofi says.

The company says the sBLA is supported by data from the pivotal Phase 3 trial evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. Sanofi says the trial met all primary and secondary endpoints, showing that Dupixent and topical corticosteroids significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to topical corticosteroids alone.