Cytokinetics: FDA Reverses Course, Plans AdCom Meeting on Omecamtiv Mecarbil
May 17 2022 - 8:26AM
Dow Jones News
By Colin Kellaher
Cytokinetics Inc. on Tuesday said the U.S. Food and Drug
Administration now plans to hold an advisory committee meeting on
the company's proposed heart drug omecamtiv mecarbil.
The South San Francisco, Calif., biopharmaceutical company,
which is seeking approval of omecamtiv mecarbil for the treatment
of heart failure with reduced ejection fraction, said it expects
the FDA to inform it of the date and topics for the meeting at a
later date.
Cytokinetics in February said the agency had indicated that it
didn't plan to hold an advisory committee meeting. The FDA has set
a target action date of Nov. 30 for the company's application
seeking approval of omecamtiv mecarbil.
According to the FDA's website, the agency often turns to
advisory committees to obtain advice from experts who work outside
of the government when a scientific, technical or policy question
arises, such as whether an unapproved product is safe and
effective.
The FDA usually follows the advice of its advisory committees,
but it isn't bound by the recommendations.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 17, 2022 08:11 ET (12:11 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Apr 2023 to Apr 2024
