The Food and Drug Administration requires more time to study Cytokinetics’ omecamtiv mecarbil following analysis of some additional data.
FDA approval delayed for Cytokinetics’ heart drug by three months, from November 30, 2022, to February 28, 2023, the company confirmed via an announcement on Friday. The decision to delay came from new data that was revealed following additional pharmacokinetic analyses, which was believed to be an important alteration in the application of the new drug.
Cytokinetics is a 25-year-old publicly traded American late-stage biopharmaceutical company based in Southern San Francisco, California. It is known for developing muscle inhibitors and muscle activators as possible treatments for patients suffering from declining or compromised muscle function.
This is the latest barrier to the approval of omecamtiv mecarbil, which is in consideration for the treatment of heart failure. After originally denying the need for a meeting to discuss the therapy, the FDA announced in May, that they decided to organize an advisory committee meeting for the same reason. The meeting is not scheduled as yet, but it is evident that FDA is taking time to consider Cytokinetics heart drug.
“We are working collaboratively with the FDA as they conduct their review of omecamtiv mecarbil. We are committed to bringing forward our first-in-class cardiac myosin activator, which may provide an important treatment option for patients suffering from worsening heart failure,” said Robert Blum, CEO, along with Cytokinetics President in a statement on Friday.
In addition, a Cytokinetics spokesperson said that the delay is an indication of vigilant consideration of the latest pharmacokinetic data, which may mean that the agency is potentially inclined towards approval. The spokesperson noted that the industry has seen similar delays in approvals and Cytokinetics is not the only one to face delays. Other companies, including Bristol Myers Squibb also encountered delays for their latest drug applications, and were later granted the approval. The drug in question was BMS’s mavacamten, a heart drug that was approved after a year-long delay, in April. It is now marketed as Camzyos.
In February this year, Cytokinetics reported that the drug did not improve the capacity of muscle exercise in heart failure patients with lowered ejection fraction in a phase 3 trial. This is a year into the future, after the therapy met the primary goal of a trial to diminish heart failure events or even cardiovascular death in comparison to a placebo. However, it failed a secondary endpoint that focused on cardiovascular death.
Even though the primary goal was a success, the result was the forced exit of partner Amgen. Following the partner’s exit, Cytokinetics has since been handling the regulatory process on its own.
As of Friday, Cytokinetics’ shares were steady at $40 per share. The company also has sufficient cash in hand. As of March 31, stated cash in hand stood at $686.1M.
In January, Cytokinetics partnered with Royalty Pharma to distribute their heart failure drug to the rest of the world, after offloading China’s rights to the drug. According to this partnership, Royalty will pay about $450M for the opportunity to support omecamtiv mecarbil’s commercial launch. With access to $150M of funds right away, Cytokinetics will have a cash runway of minimum for the next couple of years.