Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria

Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the US suffer from chronic spontaneous urticaria (CSU) that is inadequately controlled by antihistaminesFDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade Paris and Tarrytown, NY, November 15, 2024. The US Food and Drug ...