FDA approves ISDN-hydralazine combo for African Americans with HF

June 24, 2005

Washington, DC - The US Food and Drug Administration (FDA) yesterday approved the fixed-dose combination of isosorbide dinitrate (ISDN) and hydralazine called BiDil (NitroMed) for use specifically in self-identified African Americans. The decision marks the first time the agency has okayed a drug for the marketplace while limiting its indication to a specific race.

As reported by heart wire , last week the FDA's Cardiovascular and Renal Drugs Advisory Committee voted unanimously to recommend BiDil's approval based on the strength of the landmark African American Heart Failure Trial (A-HeFT) [1]. It randomized 1050 self-reported black patients with HF to receive BiDil or a placebo. Actively treated patients initially received a tablet containing 20 mg of the nitrate and 37.5 mg of hydralazine three times daily on top of standard therapy.

A-HeFT's data monitoring board halted the trial before its planned 1100 patients had been enrolled when it observed an early, significant mortality increase in the placebo group. The reported ultimate outcomes of a 43% drop in mortality and 39% decrease in HF hospitalizations among actively treated patients covered a mean follow-up of 10 months.

"In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil," said Dr Robert Temple, the FDA's associate director of medical policy, in a press release.

The remark is an apparent reference to hopes that specific genetic markers can be found that will identify persons more likely to respond to the newly approved drug, not to mention other drugs, instead of relying on indicators as subjective as skin color or self-reported race.

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