FDA ADVISORY COMMITTEE RECOMMENDS APPROVAL FOR NITROMED'S BIDIL

The FDA's Cardiovascular and Renal Drugs Advisory Committee voted to recommend approval of NitroMed's product candidate BiDil (isosorbide dinitrate/hydralazine HCl) for the treatment of heart failure in black patients.

In the African American Heart Failure Trial (A-HeFT), black patients taking BiDil in addition to current standard heart failure therapies experienced a 43 percent decrease in the risk of mortality, a 39 percent reduction in the risk of first hospitalizations for heart failure and an improvement in quality of life versus patients taking placebo in addition to current standard therapies. A-HeFT was designed as a confirmatory trial after earlier studies suggested a response in black patients.

A-HeFT, co-sponsored by NitroMed and the Association of Black Cardiologists (ABC), enrolled 1,050 patients who self-identified as black and was the first trial ever conducted in an all African-American heart failure population. Adverse events reported in the trial and seen more frequently in the group given BiDil included symptoms of headache and dizziness. Exacerbations of moderate and severe heart failure were seen more frequently in the placebo group.