Merck Gets FDA Priority Review of Vericiguat New Drug Application
July 16 2020 - 7:41AM
Dow Jones News
By Colin Kellaher
Merck & Co. on Thursday said the U.S. Food and Drug
Administration accepted and granted priority review to its new drug
application for vericiguat, which it is jointly developing with
Bayer AG.
The Kenilworth, N.J., drug maker said it is seeking approval of
vericiguat to reduce the risk of cardiovascular death and
heart-failure hospitalization following a worsening heart-failure
event in patients with symptomatic chronic heart failure with
reduced ejection fraction, in combination with other heart-failure
therapies.
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 to
six months from the standard 10 months. Merck said the agency set a
target action date of Jan. 20, 2021, for the application.
Merck and Germany's Bayer have been collaborating in the field
of soluble guanylate cyclase modulators such as vericiguat since
October 2014.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 16, 2020 07:26 ET (11:26 GMT)
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