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.
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.
For more information visit Arcabiopharma.com.