FDA accepts resubmission of sBLA for Dupixent for chronic spontaneous urticaria
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Key takeaways:
- The resubmission included new data from a phase 3 program which showed Dupixent reduced itchiness and hives.
- The FDA set a target action date for April 18, 2025.
The FDA has accepted the resubmission of the supplemental biologics license application for Dupixent to treat chronic spontaneous urticaria in adults and children, Regeneron Pharmaceutical and Sanofi announced in a press release.
The application of Dupixent (dupilumab; Regeneron, Sanofi) is specifically indicated for patients aged at least 12 years with chronic spontaneous urticaria that cannot be adequately controlled with H1 antihistamines.
The resubmission included new data from a phase 3, multi-trial, clinical program called LIBERTY-CUPID, which showed that itchiness and hives from urticaria were significantly reduced with Dupixent.
The trials also reported that Dupixent’s safety profile for the treatment of chronic spontaneous urticaria was consistent with its approved indications.
The FDA has set a target action date for April 18, 2025.