The FDA will convene an advisory committee to discuss Cytokinetics inconsistent heart failure med after all, more than three months after the agency first indicated it would not.
A date or topic list for the meeting has not yet been set but the company expects that to happen later this year; the FDA-set deadline to approve the med remains November 30. The agency had originally indicated earlier this year that it would not hold an advisory committee meeting, according to a release from the company in February.
Omecamtiv mecarbil has had a bumpy trip through the clinic. The FDA’s change of heart disclosed by the company is the latest news, after Cytokinetics announced that the therapy failed to improve exercise capacity among heart failure patients with reduced rejection in a phase 3 trial in February.
