Bayer Stops Late-Stage Study for Stroke Prevention Due to Lack of Efficacy
20 Noviembre 2023 - 1:22AM
Noticias Dow Jones
By Helena Smolak
Bayer is discontinuing early a Phase 3 study to test
investigational drug asundexian on prevention of stroke and
systemic embolism for patients with atrial fibrillation due to lack
of efficacy.
The German pharmaceutical-and-agricultural group said late
Sunday that the decision is based on a recommendation by the
independent data monitoring committee of the study.
The study evaluated the efficacy and safety of asundexian--an
oral inhibitor of a protein involved in blood coagulation called
Factor XIa--against apixaban, but showed an inferior efficacy of
asundexian, Bayer said.
Available safety data are consistent with previously reported
safety profiles of asundexian, the company said.
Bayer will continue to analyze the data to better understand the
outcome and publish the data, it said.
The company is currently reevaluating other indications in
patients who need antithrombotic treatment, said Christian Rommel,
head of research and development at Bayer's pharmaceuticals
division.
Write to Helena Smolak at helena.smolak@wsj.com
(END) Dow Jones Newswires
November 20, 2023 02:07 ET (07:07 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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