Shots:

• The NDA was based on the P-III (GALACTIC-HF) trial to evaluate omecamtiv mecarbil vs PBO in ~8000 patients with HFrEF in 35 countries across 945 sites. The US FDA has assigned the PDUFA date of Nov 30, 2022
• The results showed a significant effect of treatment to reduce risk of the primary composite EPs of CV death or HF events while additional analyses demonstrated a greater treatment effect in patients with lower LVEF along with other characteristics & no reduction in 2EPs of time to CV death
• In preclinical research, the therapy increased cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption

Ref: Globe Newswire | Image: STAT News