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Amgen, Cytokinetics Checked With Payers Before Taking Omecamtiv Into Phase III

 
• By Joseph Haas

Partnered on chronic heart failure drug omecamtiv mecarbil, Amgen and Cytokinetics took months to design a Phase III trial that would address the needs and concerns of both payers and clinicians.

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The long-awaited announcement of whether Amgen Inc. and partner Cytokinetics Inc. would move chronic heart failure candidate omecamtiv mecarbil into pivotal Phase III studies was answered affirmatively Sept. 1, with the decision reflecting extensive consultation with regulators and payers to design a clinical trial that can deliver the right data to find a place in the market for the novel cardiac myosin activator.

The drug has a somewhat troubled past – failing in a Phase II study in 2013 that tested an intravenous injection formulation with a primary endpoint of treating breathing difficulty...

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