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news.The US Food and Drug Administration (FDA) has granted fast track designation for ARCA biopharma's Gencaro for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure population.
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Gencarois, the company’s investigational, pharmacologically unique beta-blocker and mild vasodilator, is indicated for heart failure patients with reduced left ventricular ejection fraction (HFREF).
Currently, Gencaro is being evaluated as a potential treatment for atrial fibrillation in a genetically-defined heart failure (HFREF) population in GENETIC-AF, a Phase IIb/III adaptive design clinical trial.
The company expects that enrollment of around 200 patients in the Phase IIb portion of the trial will be completed by the end of 2016.
ARCA president and chief executive officer Michael Bristow said: "We view Fast Track designation for the Gencaro development program as an important acknowledgement of the need for advancements in the treatment of atrial fibrillation in heart failure patients.
"Atrial fibrillation afflicts over 2.7 million people in the United States with 250,000 to 500,000 new cases diagnosed each year.
"We believe we have a significant opportunity to improve the treatment options for heart failure patients living with atrial fibrillation."
A DNA sub-study of patients from the BEST Phase III heart failure mortality trial of Gencaro showed that the combinations of beta-1 389 and alpha-2C polymorphisms in individual patients in the trial appeared to influence the response to Gencaro.