Cytokinetics: FDA Reverses Course, Plans AdCom Meeting on Omecamtiv Mecarbil

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By Colin Kellaher

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Cytokinetics Inc. on Tuesday said the US 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.

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Cytokinetics in February said the agency had indicated that it didn’t plan to hold an advisory committee meeting.
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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 isnt bound by the recommendations.

Write to Colin Kellaher at [email protected]

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Credit: www.marketwatch.com /

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