May 14, 2020 / 5:34 AM / 17 days ago

Sanofi gets priority U.S. FDA review for sutimlimab product

FILE PHOTO: The logo of Sanofi is seen at the company's headquarters in Paris, France, April 24, 2020. REUTERS/Charles Platiau

PARIS (Reuters) - French healthcare company Sanofi said on Thursday that the U.S. Food & Drug Administration (FDA) regulator had granted a priority review for Sanofi’s sutimlimab product, which treats hemolysis in adults suffering from cold agglutinin disease.

Sanofi said that if it won full regulatory approval, sutimlimab would be the first and only approved treatment forsuch patients. The target action date for the FDA decision is November 13, 2020, Sanofi said. 

Reporting by Sudip Kar-Gupta; Editing by Tom Hogue

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