FDA staff reviewers flag safety concerns over Cytokinetics' heart drug

[December 10, 2022]  (Reuters) -U.S. Food and Drug Administration staff reviewers on Friday identified safety and efficacy concerns about Cytokinetics Inc's heart drug, according to briefing documents published on the agency's website.

The late-stage data raises concerns about the drug's dose-limiting risks of heart failure, the reviewers said, adding it is unclear if the study would be enough to provide evidence of the treatment's effectiveness.

A panel of the health regulator's outside experts is scheduled to discuss approval on Dec. 13, and a decision is expected by Feb. 28.

The draft questions for the upcoming meeting were in line with expectations and the advisory committee may want to see additional data or analyses before recommending approval, analysts said.

The company's experimental drug, omecamtiv mecarbil, aims to reduce the risk of heart-related death or the need for hospitalization or other urgent care.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

"We believe a mixed or even negative advisory committee meeting outcome is positive for the stock," said Piper Sandler analyst Yasmeen Rahimi, adding this would allow Cytokinetics to re-allocate its resources to aficamten, which is being evaluated as a treatment for an inherited heart condition.

Omecamtiv works by activating cardiac myosin, a protein in heart muscle cells responsible for converting chemical energy into the mechanical force that drives cardiac contraction.

Shares of the California-based company rose nearly 8% before giving up nearly all the gains.

(Reporting by Bhanvi Satija and Pratik Jain in Bengaluru; Editing by Sriraj Kalluvila)

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