FDA Panel Shoots Down Cytokinetics Bid for Second Heart Drug Approval

December 14, 2022 by TWN Staff
FDA Panel Shoots Down Cytokinetics  Bid for Second Heart Drug Approval
This Thursday, Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md. (Associated Press)

WASHINGTON — A panel of advisors to the Food and Drug Administration on Tuesday declined to recommend approval of a new heart drug created by biotech firm Cytokinetics, finding the benefits of the drug do not outweigh its risks.

The FDA is not required to follow the recommendations of its independent advisors, but the 8-3 vote strongly suggests omecamtiv mecarbil is likely to be rejected.

“We are disappointed there was not a greater consensus among committee members relating to the benefit-risk of omecamtiv mecarbil, and we maintain our conviction in the strength of evidence supporting its potential benefit for patients suffering from HFrEF,” said Robert I. Blum, Cytokinetics’ president and chief executive officer, in a written statement issued Tuesday night. 

“We continue to believe omecamtiv mecarbil can be a valuable add-on therapy for patients with worsening heart failure who remain at high risk for heart failure events and hospitalization despite treatment with available guideline-directed medical therapy,” Blum said. 

“We plan to engage constructively with FDA as it completes its review of the application for omecamtiv mecarbil.”

Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator. If approved by the FDA, it would become the first therapy indicated for HFrEF that directly targets the mechanisms of the heart responsible for contraction — or its pumping function.

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