By Pratik Jain
(Reuters) – The U.S. Food and Drug Administration’s panel of outside experts did not lend its support to Cytokinetics Inc’s heart drug, citing insufficient data on safety and efficacy.
The panel voted 8-3 against recommending use of the drug, omecamtiv mecarbil, for treating patients with a type of heart failure caused by abnormal contractions in the main pumping chamber of the heart.
“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.
The panel also suggested Cytokinetics gather additional data on the drug’s ability to reduce the risk of heart-failure related death.
The company’s application to the FDA was based on results from a late-stage study of over 8,000 patients in which 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 key role in improving the pumping function of the heart.
The trial data, however, showed a slightly higher rate of cardiovascular-related death in patients who were given the drug compared to those on placebo.
FDA staff reviewers had raised concerns about the drug’s safety, especially at higher doses, in briefing documents released last week.
Cytokinetics said it plans to continue engaging in discussions with the health regulator until the review is complete. The FDA, which usually follows the recommendations of its expert panel but is not obligated to do so, is expected to make its final decision on the drug by Feb. 28.
(Reporting by Pratik Jain and Bhanvi Satija in Bengaluru; Editing by Shinjini Ganguli)
