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November 15, 2024

FDA to review Sanofi, Regeneron’s Dupixent sBLA for CSU

The US Food and Drug Administration (FDA) has accepted for review the supplemental biologics license application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) to treat chronic spontaneous urticaria (CSU) in adults and children aged 12 and above, particularly for those whose condition persists despite H1 antihistamine treatment.

FDA to review Sanofi, Regeneron’s Dupixent sBLA for CSU