Sanofi: new sBLA for Dupixent in urticaria

(CercleFinance.com) - Sanofi announces that the US FDA has agreed to review a new supplemental Biologics License Application (sBLA) for its Dupixent (dupilumab) in the treatment of chronic spontaneous urticaria (CSU).


This dossier concerns the treatment of adult and pediatric patients aged 12 and over, whose disease is not adequately controlled by H1 antihistamine therapy. The target action date for the FDA's decision is 18 April 2025.

This new sBLA is supported by data from the LIBERTY-CUPID Phase 3 clinical program for Dupixent in UCS, which confirms that Dupixent significantly reduces itching and hives activity.

More than 300,000 people in the US have UCS inadequately controlled by antihistamines. If approved, Dupixent would be the first targeted therapy for UCS in a decade, Sanofi says.


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