Arca Biopharma Inc (NASDAQ:ABIO) gets FDA Fast Track Designation for Gencaro, Shares Soar 22% Print
By Marilyn Mullen   
Monday, 13 April 2015 14:15

Biopharmaceutical firm, Arca Biopharma Inc. (NASDAQ:ABIO), has confirmed that the U.S. Food and Drug Administration (FDA) has given a Fast Track development program for investigating Gencaro that prevents a trial fibrillation in a genetically modified heart failure population. ARCA develops genetically-targeted therapies for cardiovascular diseases whereas Gencaro is the firm’s investigational beta-blocker as well as mild vasodilator. Fast Track programs are aimed to make it easy for developing as well as expediting review of new drugs which look to treat life-threatening conditions and which show the potential for addressing unmet medical needs.

ARCA is expecting enrollment of about 200 patients in Phase 2B portion of trial that would be finished by 2016 end.

Michael R. Bristow, President and Chief Executive Officer of ARCA, opined that the Fast Track designation for Gencaro development program shows how vital is the requirement for advancements in treating a trial fibrillation in heart failure patients.

He added that the condition affects over 2.7 million people in United States with 250,000 to 500,000 new cases diagnosed each year. Bristow is of the view that it is an important chance for improving treatment options for heart failure patients.

The Fast Track drug development designation was done in FDA Modernization Act of 1997 for enhancing interactions with FDA during drug development.

Such a program makes it easy for scheduling meetings for seeking FDA input into development plans as well as priority review of New Drug Application (NDA) along with an option of submitting portions of NDA for review before submission of complete application as well as potential accelerated approval.

Atrial fibrillation is a common sustained cardiac arrhythmia and figures that such individuals globally in 2010 were 33.5 million. AF leads to more risk of morbidity as well as mortality because of stroke and impaired quality of life.

Shares of the company soared 22% to $1.02 on hefty volume of 6.42 million shares.

 




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