Bristol-Myers: FDA Extends Review of Heart-Drug Mavacamten by Three Months
19 November 2021 - 11:49PM
Dow Jones News
By Colin Kellaher
Bristol-Myers Squibb Co. on Friday said the U.S. Food and Drug
Administration has extended its review of mavacamten by three
months to allow more time to assess a safety program for the
proposed heart drug.
The New York biopharmaceutical company said the agency extended
its target action date to April 28 from Jan. 28 to review updates
to a program known as a risk evaluation mitigation strategy, or
REMS, which was included in the initial application for
mavacamten.
The FDA can require REMS for certain drugs with serious safety
concerns to help ensure the benefits of the medication outweigh its
risks.
Bristol-Myers said the agency didn't request any further data or
studies, adding it is confident in the profile of mavacamten, a
first-in-class myosin inhibitor developed to address the underlying
molecular defect of hypertrophic cardiomyopathy, the most common
inherited heart disease.
Mavacamten was the lead product candidate of MyoKardia Inc.,
which Bristol-Myers bought last year for about $13.1 billion.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 19, 2021 07:34 ET (12:34 GMT)
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