NitroMed, Inc. announced that the US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted to recommend approval of its product candidate BiDil (isosorbide dinitrate/hydralazine hydrochloride) for the treatment of heart failure in black patients.
"The Committee's recommendation to approve BiDil represents an important step forward in our ability to make this treatment available," said Manuel Worcel, M.D., NitroMed's chief medical officer. "We believe that, if approved by the FDA, BiDil will provide new hope to black heart failure patients who suffer a disproportionate burden of this disease."
In the African American Heart Failure Trial (A-HeFT), black patients taking BiDil in addition to current standard heart failure therapies experienced a 43 per cent decrease in the risk of mortality (10.2 per cent vs. 6.2 per cent; P=0.012), a 39 per cent reduction in the risk of first hospitalizations for heart failure (16.4 per cent vs. 24.4 per cent; P<0.001) and an improvement in quality of life (P=0.02) 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 (49.5 per cent in BiDil patients vs. 21.1 per cent in placebo patients) and dizziness (31.9 per cent in BiDil patient vs. 13.7 per cent in placebo patients). Exacerbations of moderate and severe heart failure were seen more frequently in the placebo group.
Heart failure, also called congestive heart failure or dilated cardiomyopathy, is a degenerative condition that occurs when the heart muscle weakens and cannot pump blood efficiently to meet the metabolic needs of the body, often resulting in fatigue and shortness of breath. The loss of the heart's pump function is usually caused by an underlying condition, such as hypertension or coronary artery disease, which weakens the heart muscle and increases a person's risk of heart failure.
Heart failure affects approximately five million Americans and is the primary reason for hospitalizations among people over the age of 65. It is also one of the most expensive diseases faced by Americans, costing more than all cancers combined. An estimated 750,000 African Americans are currently diagnosed with heart failure, with the number expected to increase to nearly 900,000 by 2010. There is no cure for this disease, and more than 50 per cent of patients die within five years of diagnosis.
NitroMed completed its resubmission of a new drug application for BiDil in December 2004 for the treatment of black patients with heart failure. According to goal action dates set by FDA under the Prescription Drug User Fee Act (PDUFA), NitroMed is expecting a response from the FDA by June 23.