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 in heart failure patients compared to placebo. (Also see "Amgen, Cytokinetics' heart drug misses goal in Phase II study" - Scrip, 3 September, 2013
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