FDA Adcomm Gives Thumbs Down To Cytokinetics' Heart Failure Candidate

The FDA's Cardiovascular and Renal Drugs Advisory Committee voted 8-3 against the approval of Cytokinetics Incorporated's 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.