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FDA Adcom Votes Against (3-8) Omecamtiv Approval

Here is a brief preview of this blast: Today, FDA held an advisory committee meeting to discuss the use of Cytokinetics’s omecamtiv to reduce the risk of CV death and HF events in patients with HFrEF, and panelists voted overwhelmingly against (3-8) the omecamtiv benefit/risk profile. For context, in June 2022, FDA accepted the omecamtiv NDA and set a PDUFA date for February 28, 2023 (previous FENIX insight). Recall, the NDA submission is based on data from the Ph3 GALACTIC-HF trial (view CT.gov record) which were initially presented at AHA 2020 (previous FENIX insight) and published in the NEJM (view publication). Below, FENIX provides key commentary from the adcom panel as well as insight on the future for the asset.

About The Author

Matthew Maryniak

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President of Fenix Group International
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.