Posted by Michael Wonder on 15 Nov 2024
Dupixent (dupilumab) sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria
15 November 2024 - Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity.
Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has accepted for review the resubmission of the supplemental biologics license application for Dupixent (dupilumab) to treat adults and paediatric patients aged 12 years and older with chronic spontaneous urticaria whose disease is not adequately controlled with H1 anti-histamine treatment.
