The FDA has accepted the resubmission of the supplemental biologics license application for Dupixent, a drug used to treat chronic spontaneous urticaria in adults and children. The resubmission included data from a phase 3 program showing that Dupixent reduced itchiness and hives. The FDA has set a target action date for April 18, 2025. The drug is specifically indicated for patients aged at least 12 years with chronic spontaneous urticaria that cannot be adequately controlled with H1 antihistamines. Trials also reported that Dupixent’s safety profile for the treatment of chronic spontaneous urticaria was consistent with its approved indications.
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FDA accepts resubmission of sBLA for Dupixent for chronic spontaneous urticaria
