BROOMFIELD, Colo. (AP) — The FDA wants ARCA Biopharma Inc. to run more clinical tests on its heart failure drug candidate Gencaro before it will consider approving the product. The FDA asked for additional studies to prove Gencaro is effective in preventing death from chronic heart failure, and to get more information on how the medicine interacts with other drugs. It also asked for additional non-clinical studies. ARCA did not say how long the additional studies could delay approval of the product. ARCA’s application to the FDA included data from a late-stage trial called BEST. The company said the FDA determined that the trial results do not prove Gencaro reduces death in patients with heart failure. The agency also had questions about integrity of data, and as a result, ARCA said it may have to conduct an independent audit of some of the sites involved in the trial. The agency also questioned the significance of data that ARCA said shows a patient’s genetic makeup predicts his or her response to Gencaro. ARCA said it submitted additional information on Gencaro in May. The FDA has not yet reviewed that information, and the company said that submission may address some of the FDA’s concerns.
