The decision – by eight votes to three – came mainly because panellists were unconvinced by the efficacy of the drug in heart failure with reduced ejection fraction (HFrEF), and so were uncomfortable with its side effects, which include cardiotoxicity such as myocardial ischemia.
In a statement, Cytokinetics said it was “disappointed there was not a greater consensus amongst committee members relating to the benefit-risk of omecamtiv mecarbil,” adding that it remains convinced of “the strength of evidence supporting its potential benefit for patients suffering from HFrEF.”
