Cytokinetics Announces FDA Acceptance of New Drug - GlobeNewswire
FDA accepted Cytokinetics' NDA for omecamtiv mecarbil, targeting HFrEF, with a PDUFA action date of November 30, 2022. No advisory committee meeting is planned. GALACTIC-HF trial showed omecamtiv mecarbil reduced CV death or heart failure events risk. METEORIC-HF results expected early 2022.
Reference News
Cytokinetics Announces FDA Acceptance of New Drug - GlobeNewswire
FDA accepted Cytokinetics' NDA for omecamtiv mecarbil, targeting HFrEF, with a PDUFA action date of November 30, 2022. No advisory committee meeting is planned. GALACTIC-HF trial showed omecamtiv mecarbil reduced CV death or heart failure events risk. METEORIC-HF results expected early 2022.