HQ Team
March 1, 2023: Cytokinetics, a US-based biopharmaceutical company, announced the FDA had rejected its new drug application for approving a trial drug to treat heart problems with reduced ejection fraction (HFrEF).
The FDA issued a complete response letter that discarded omecamtiy microbial, meant for patients with reduced ejection fraction, according to a company statement.
The global approach to lowering adverse cardiac outcomes through improving contractility in heart failure (GALACTIC-HF) is “not sufficiently persuasive” to establish evidence of reducing the risk, according to the US regulatory agency.
The FDA concluded after the company provided evidence from about two clinical investigations.
A complete response letter reflects the FDA’s full review of the data submitted in an original or abbreviated application or a resubmission and any amendments the agency has reviewed.
The complete response letter will identify any amendments the agency needs to review.
‘Disappointed’
“We are disappointed with this outcome, especially considering the high unmet need for innovative treatments for patients suffering from worsening heart failure,” said Robert I. Blum, Cytokinetics’ President & Chief Executive Officer.
According to the statement, the FDA stated that results from an additional clinical trial of omecamtiy mecarbil are required to establish substantial evidence of effectiveness for the treatment, with benefits that outweigh the risks.
GALATIC-HF was a phase 3 clinical trial of omecamtiy mecarbil that enrolled patients with HFrEF at risk of hospitalization and death, despite being treated with standard-of-care therapy.
Cytokinetics expects to request a meeting with FDA to understand the FDA’s views regarding the certificate revocation list and what may be required to support potential approval of omecamtiy mecarbil.
However, the company has no plans to conduct an additional clinical trial of the drug. Its focus remains on the development program for aficamten, undergoing clinical trials in patients with obstructive hypertrophic cardiomyopathy.
Aficarmten
“We will engage with FDA and consider the next steps for omecamtiy mecarbil in the US. In parallel, we look forward to continuing a broad development program for aficarmten, “with expected results for the start of two more Phase 3 clinical trials later this year, Mr Blum said.
Heart failure affects more than 64 million people worldwide5, about half of whom have reduced left ventricular function. It is the leading cause of hospitalization and readmission in 65 and older.
An estimated one in five people over 40 are at risk of developing heart failure, and approximately 50% of people diagnosed with heart failure will die within five years of initial hospitalization.
About two million people in the US are estimated to have an ejection fraction of less than 30%, indicating they may have worsening heart failure.
