French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) on Thursday announced positive phase 3 data for Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU).
Taken in conjunction with standard-of-care histamine-1 (H1) antihistamines, the drug significantly reduced itch and hive activity, with 41% of patients achieving well-controlled disease status.
These results support Sanofi's plans to resubmit Dupixent for US regulatory approval by year-end. If approved, Dupixent would be the first new targeted treatment for CSU in over a decade.
More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines.
Dupilumab is being jointly developed by Sanofi and US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) under a global collaboration agreement.
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