Dupixent® (dupilumab) sbla accepted for fda review for the treatment of chronic spontaneous urticaria (csu)

Resubmission includes new pivotal data which confirm dupixent significantly reduced itch and hive activity more than 300,000 people in the u.s. suffer from csu that is inadequately controlled by antihistamines fda decision expected by april 18, 2025; if approved, dupixent would be the first targeted therapy for csu in a decade tarrytown, n.y. and paris, nov. 15, 2024 (globe newswire) -- regeneron pharmaceuticals, inc. (nasdaq: regn) and sanofi today announced that the u.s. food and drug administration (fda) has accepted for review the resubmission of the supplemental biologics license application (sbla) for dupixent® (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (csu) whose disease is not adequately controlled with h1 antihistamine treatment.
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