By Colin Kellaher


Sanofi S.A. on Thursday said the U.S. Food and Drug Administration granted priority review to its biologics license application for sutimlimab for the treatment of hemolysis in adults with cold agglutinin disease.

The Paris drug maker said sutimlimab, if approved, would be the first and only approved treatment for these patients.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. Sanofi said the agency set a target action date of Nov. 13 for the application.

Cold agglutinin disease is a chronic autoimmune hemolytic anemia that causes the body's immune system to mistakenly attack healthy red blood cells and cause their rupture, or hemolysis.


Write to Colin Kellaher at


(END) Dow Jones Newswires

May 14, 2020 06:33 ET (10:33 GMT)

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