Sanofi's Sutimlimab Gets FDA Priority Review for Hemolysis in Cold Agglutinin Disease
May 14 2020 - 6:48AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 14, 2020 06:33 ET (10:33 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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