Bayer Gets FDA Approval for Heart-Failure Drug Vericiguat
January 20 2021 - 7:26AM
Dow Jones News
By Cecilia Butini
Bayer AG said Wednesday that the U.S. Food and Drug
Administration has granted approval to its heart-failure drug
Vericiguat, also known by its brand name Verquvo.
The German chemical and pharmaceutical conglomerate said the
drug was developed jointly with Merck Sharp & Dohme Corp.,
which retains commercial rights to Vericiguat in the U.S. Bayer has
exclusive commercial rights in the rest of the world, the company
said.
The FDA approval was granted on the basis of results from the
pivotal phase 3 Victoria clinical trial and follows priority review
designation from the U.S. agency.
The drug is indicated to reduce the risk of cardiovascular death
and heart failure hospitalization in adults with symptomatic
chronic heart failure, Bayer said.
It has been submitted for marketing authorization in the
European Union, Japan, China and other countries world-wide, Bayer
said.
Write to Cecilia Butini at cecilia.butini@wsj.com
(END) Dow Jones Newswires
January 20, 2021 07:11 ET (12:11 GMT)
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