Gencaro Fast Tracked for A-fib in Genetically Modified Heart Failure

ARCA Biopharma announced that the Food and Drug Administration (FDA) has granted Fast Track designation to Gencaro (bucindolol HCl; ARCA Biopharma) for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure population (heart failure patients with reduced left ventricular ejection fraction [HFREF]). Gencaro is a unique, investigational beta-blocker and mild vasodilator.

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Gencaro is currently being evaluated as a potential treatment for atrial fibrillation in a genetically-defined heart failure population in GENETIC-AF, a Phase 2b/3 adaptive design clinical trial. ARCA anticipates that enrollment of approximately 200 patients in the Phase 2b portion of the trial will be completed by the end of 2016.

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