Posted by Michael Wonder on 01 Mar 2023
Cytokinetics receives complete response letter from FDA for new drug application for omecamtiv mecarbil
28 February 2023 - Complete response letter states that GALACTIC-HF alone does not establish substantial evidence of effectiveness sufficient for approval.
Cytokinetics today announced that the US FDA issued a complete response letter regarding the new drug application for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator, for the treatment of heart failure with reduced ejection fraction.
