Merck and Co. said Friday its heart failure treatment rolofylline missed its goals in a trial, failing to improve patient symptoms compared with a placebo.
The company said rolofylline did not reach its primary or secondary goals in the late-stage trial. Based on the results, Merck said it no longer plans to ask the Food and Drug Administration to approve the drug candidate this year.
The trial also showed that 30 mg of rolofylline did not reduce the risk of death or hospitalization due to heart or kidney problems 60 days after treatment, and that it did not reduce kidney impairment.
Merck is still analyzing study data from the study, which is called PROTECT, and it will present full results from the 2,033-patient trial at a medical conference later this year.
Date: June 5, 2009
Source: Associated Press