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# FDA Panel Thumbs Down on Heart Failure Drug
- URL: https://www.fdaweb.com/fda-panel-thumbs-down-on-heart-failure-drug/
- Published: 2022-12-14T12:00:00.000Z
- Updated: 2026-09-14T18:09:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153403

FDA’s Cardiovascular and Renal Drugs Advisory Committee has voted 8 to 3 against recommending approval of Cytokinetics’ omecamtiv mecarbil for treating heart failure (HF) with reduced ejection fraction. The NDA included data from the phase 3 GALACTIC-HF trial which evaluated 8,256 adults who were either hospitalized for heart failure or had a hospitalization within one-year prior to screening. The primary efficacy endpoint was the time to a first HF event (i.e., hospitalization, emergency department treatment, urgent clinic visit) or CV death.

Panel members mostly agreed with an FDA [briefing document](https://www.fda.gov/media/163821/download?ref=fdaweb.com), which said that the “primary efficacy results were driven by HF events with no trends of improvement on CV mortality. The small treatment effect, with a p-value that is not very persuasive for a single trial, without established effects on any of the secondary efficacy endpoints, calls into question whether the statutory requirement for substantial evidence of effectiveness has been met.” It also said the major safety concern is the drug’s “potential risk of dose-limiting cardiotoxicity including but not limited to myocardial ischemia/infarction resulting from an excessive pharmacologic effect of OM \[omecamtiv mecarbil\].”

FDA is expected to render a review decision before the user fee target date of 2/28/2023.