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# Cytokinetics Gets NDA Complete Response Letter
- URL: https://www.fdaweb.com/cytokinetics-gets-nda-complete-response-letter/
- Published: 2023-03-01T12:00:00.000Z
- Updated: 2026-09-14T18:17:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153885

FDA has issued Cytokinetics a complete response letter on its NDA for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator for treating heart failure with reduced ejection fraction (HFrEF). “FDA communicated that \[the Phase 3 GALACTIC-HF study\] is not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death in adults with chronic heart failure with reduced ejection fraction, in lieu of evidence from at least two adequate and well-controlled clinical investigations,” according to the company. The agency recommended that data from an additional clinical trial are required to establish substantial evidence of the drug’s effectiveness in treating HFrEF, “with benefits that outweigh the risks,” it adds.

Cytokinetics says it will request a meeting with FDA to clarify its views in the letter. “However,” it adds, “the company has no plans to conduct an additional clinical trial of omecamtiv mecarbil and its focus remains on the development program for aficamten*,* a next-in-class cardiac myosin inhibitor, currently the subject of SEQUOIA-HCM, a Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM).”

FDA’s letter is in line with a 12/2023 Cardiovascular and Renal Drugs Advisory Committee meeting that voted 8 to 3 against recommending approval of the drug. 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 \[omecamtiv mecarbil\].”