Cytokinetics: Complete Response Letter for Heart Failure Therapy Application

 Complete Response Letter States that GALACTIC-HF Alone Does not Establish Substantial Evidence of Effectiveness Sufficient for Approval

Company Expects to Request Meeting with FDA to Discuss Potential Next Steps

Cytokinetics to Host Conference Call and Webcast on March 1, 2023 at 8:30 am Eastern Time

Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator, for the treatment of heart failure with reduced ejection fraction (HFrEF).

FDA communicated that GALACTIC-HF is not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death in adults with chronic heart failure with reduced ejection fraction, in lieu of evidence from at least two adequate and well-controlled clinical investigations. FDA stated that results from an additional clinical trial of omecamtiv mecarbil are required to establish substantial evidence of effectiveness for the treatment of HFrEF, with benefits that outweigh the risks. GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) was a Phase 3 clinical trial of omecamtiv 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 in order to understand FDA’s views regarding the CRL and what may be required to support potential approval of omecamtiv mecarbil. However, the Company has no plans to conduct an additional clinical trial of omecamtiv mecarbil and its focus remains on the development program for aficamten, the next-in-class cardiac myosin inhibitor, currently the subject of SEQUOIA-HCM, a Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM).

Cytokinetics will host a conference call tomorrow, March 1, 2023 at 8:30 AM Eastern Time that will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the event can also be accessed by telephone by registering in advance at the following link: Omecamtiv Mecarbil Regulatory Update Call. Upon registration, participants will receive a dial-in number and a unique passcode to access the call.

https://finance.yahoo.com/news/cytokinetics-receives-complete-response-letter-223100090.html