Rolofylline Heart Failure Drug Fails FDA Approval

Merck & Co Inc has reported that rolofylline, much-awaited drug for the treatment of heart failure, did not meet the goals of a crucial late-stage test.

The medicine, which aims to treat the condition where the pumping ability of the patient’s heart is inadequate for the body’s requirements, was tested in a study involving over 2000 patients.

Dan Bloomfield, one of Merck’s executive directors, expressed disappointment that an effective cure for this hard-to-treat condition remains elusive. He also mentioned that it was too early to speculate on the future of rolofylline.

Dr. Christopher O’Connor, a lead researcher on the project, said that considering its failure to improve in-hospital symptoms and kidney function (its primary goal) and its failure to achieve fewer kidney or cardiovascular related hospitalizations after 2 months of treatment (its secondary goal), it was unlikely that the drug would “go forward for approval”.

Dr. O’Connor explained that nearly 30% of patients who receive standard treatment for kidney failure usually suffer from kidney deterioration for a number of reasons, such as excessive diuretics or declining heart function that provides insufficient blood flow to the kidney.

During initial stages of testing, rolofylline improved kidney function without undesirable side effects of the heart. Unfortunately, the drug fell short during later stages of testing.

The failure of rolofylline is the latest of several research setbacks for the company, which has a reputation of being on the cutting-edge of pharmaceutical research. In April 2008, the FDA rejected Merck’s Cordaptive cholesterol pill – a product which had the potential of being a blockbuster.

However, financial analyst Tim Anderson observed that despite the setbacks, Merck’s acquisition of Schering-Plough was a good move and he maintained his “outperform” rating on the company’s shares.