BROOMIELD - The U.S. Food and Drug Administration moved Arca biopharma Inc.'s Gencaro drug into the fast track for development.

The FDA's Fast Track development program is "designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need," according to the FDA's Web site.

Arca's drug, Gencaro, is a beta-blocker and mild vasodilator suspected of reducing cardiovascular mortality and hospitalizations in a specific set of heart failure patients.

"Fast Track designation for the Gencaro development program is an important acknowledgement of the need for advancements in the treatment of patients with chronic heart failure, a disease afflicting approximately 6 million people in the United States with approximately 550,000 new cases diagnosed each year," Michael Bristow, Arca's president and chief executive officer, said in a statement.

Now Broomfield-based Arca (Nasdaq:ABIO) plans to submit a study for the FDA's review. The study would assess the safety of Gencaro in about 3,000 patients who have chronic heart failure and the genotype that responds best to the drug.

The company plans to submit the proposal by the end of the year and begin its trial in late 2010 or early 2011.