FDA AdCom votes against omecamtiv mecarbil approval

14 December 2022

The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted eight to three that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of heart failure with reduced ejection fraction (HFrEF).

The drug is under development by the USA’s Cytokinetics, whose shares fell 6% to $36.00 in after-hours trading on Tuesday.

“We are disappointed there was not a greater consensus amongst 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 Blum, Cytokinetics’ president and chief executive.

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