French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Friday that the US Food and Drug Administration (FDA) has accepted a resubmitted supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat chronic spontaneous urticaria (CSU).

The FDA is expected to make a decision by 18 April 2025.

If approved, Dupixent would be the first targeted therapy for CSU in a decade. The resubmission is supported by data from the LIBERTY-CUPID phase 3 clinical program, which demonstrated that Dupixent significantly reduced itch and urticaria activity in patients with uncontrolled CSU.

CSU is a chronic inflammatory skin disease that affects over 300,000 people in the US. While H1 antihistamines are a common treatment, many patients experience inadequate control of their symptoms. Dupixent offers a potential new treatment option for these patients.

Dupilumab is being jointly developed by Sanofi and US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) under a global collaboration agreement.