December 13, 2022 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC)
The committee will discuss new drug application 216401, for omecamtiv mecarbil tablets, submitted by Cytokinetics, Inc. The proposed indication is to reduce the risk of cardiovascular death and heart failure events in patients with symptomatic chronic heart failure with reduced ejection fraction. The committee will discuss whether the phase 3 trial (GALACTIC-HF) establishes substantial evidence of effectiveness of omecamtiv mecarbil and whether the benefits of omecamtiv mecarbil outweigh the risks when used according to the applicant’s proposed dosing regimen.
