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)
