Bristol-Myers: FDA Extends Review of Heart-Drug Mavacamten by Three Months

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 [e-mail]

(END) Dow Jones Newswires

November 19, 2021 07:34 ET (12:34 GMT)

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