NitroMed's antihypertensive BiDil cleared FDA June 23 as the first drug approved for a race-based indication.

BiDil (hydralazine/isosorbide dinitrate) is approved for the treatment of severe heart failure in self-identified black patients. The dual vasodilator had been "approvable" since March 2001.

The approval is a notable success for NitroMed, which continued to pursue approval for a subpopulation after BiDil initially failed to demonstrate efficacy in the overall population.

"Two previous trials in the general population of severe heart failure patients found no benefit, but suggested a benefit of BiDil in black patients," FDA said in a press release.

The original BiDil application was submitted in 2000 based on the V-HeFT I and II trials, which had been conducted in the early 1980s and 1991, respectively.

BiDil's approval is based on the African-American Heart Failure Trial (A-HeFT) in 1,050 self-identified black patients. There was a 43% reduction in death and 39% decrease in hospitalization for heart failure compared to placebo, and a decrease in heart failure symptoms, FDA reported.

"In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil," FDA Office of Drug Evaluation I Acting Director Robert Temple said in a statement from the agency.

At its June 16 review of BiDil, FDA's Cardiovascular & Renal Drugs Advisory Committee concluded that race was serving as a surrogate for genomic markers (¹ Also see "NitroMed BiDil Recommended For Heart Failure In Self-Identified African-Americans" - Pink Sheet, 16 June, 2005.).

While some committee members expressed concern about the clinical trial results, the committee unanimously voted for BiDil's approval to treat heart failure, with all but two members recommending the indication be restricted to African-Americans.

Neither component of the combination had been approved for heart failure individually.

The anti-anginal isosorbide "seems to work by releasing nitric oxide at the blood vessel wall, but its effect usually wears off after half a day. Hydralazine may prevent this loss of effect," FDA explained, "but how the two drugs work together is not fully known."

Common side effects with BiDil are headache and dizziness, the agency said.

- Mary Jo Laffler

NitroMed's BiDil Approved For Heart Failure In Self-Identified Black Patients

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