Sanofi Says Sutimlimab Trial Meets Endpoints
10 Décembre 2019 - 2:27PM
Dow Jones News
By Michael Dabaie
Sanofi SA (SNY) said a Phase 3 trial of sutimlimab in people
with primary cold agglutinin disease met its primary and secondary
endpoints.
The primary efficacy outcome was a responder rate based on a
composite of an increase in hemoglobin from baseline or reaching a
hemoglobin level at the 26-week assessment timepoint, and the
absence of transfusions from Weeks 5 to 26.
Results also demonstrated rapid inhibition of hemolysis and
clinically significant improvements in anemia and fatigue within
one week of treatment, the company said.
Sanofi said it plans a U.S. Food and Drug Administration
submission in the near future.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
December 10, 2019 08:12 ET (13:12 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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