- The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8-3 against the approval of Cytokinetics Incorporated’s (NASDAQ:CYTK) heart failure drug, omecamtiv mecarbil.
- Adcomm members said the drug’s potential benefits did not seem to outweigh its risks, with panel members raising concerns about its safety and limited efficacy.
- The company’s application to the FDA was based on results from a late-stage study of over 8,000 patients. The drug met trial goals of reducing the risk of heart failure-related death or the need for hospitalization and other urgent care.
- Omecamtiv mecarbil is designed to increase the activity of myosin, a protein that plays a crucial role in improving the heart’s pumping function.
- In briefing documents, FDA reviewers said that the late-stage data raises concerns about the drug’s dose-limiting risks of heart failure. It is unclear if the study would be enough to provide evidence of the treatment’s effectiveness.
- The FDA also clarified the uncertainties ahead of the adcomm, noting that “the overall treatment effect was modest” in the pivotal GALACTIC-HF trial.
- “The level of evidence afforded by a single clinical trial does not give sufficient comfort to state that the drug’s benefit outweighs its risks,” said panel member Csaba Kovesdy, Reuters reported.
- Price Action: CYTK shares are down 8.17% at $35.20 during after-hours trading on Tuesday.
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