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Cytokinetics To Move On From Omecamtiv After FDA’s Complete Response Letter

 
• By Joseph Haas

Company said it will not conduct the additional Phase III trial recommended by the US FDA. Instead, it will focus on its cardiac myosin inhibitor, aficamten, and look for partners to take omecamtiv forward.

Shuffling
Cytokinetics reshuffles its R&D strategy following FDA complete response letter • Source: Shutterstock

Cytokinetics, Inc. announced 1 March that it will focus now on a different heart failure drug candidate, aficamten, having received a widely anticipated complete response letter from the US Food and Drug Administration on 28 February for omecamtiv in heart failure with reduced ejection fraction (HFrEF), following a negative advisory panel in December.

“FDA stated that results from an additional clinical trial of omecamtiv are required to establish substantial evidence of effectiveness for the treatment of HFrEF with benefits that outweigh the risks,” Cytokinetics CEO Robert

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