The Food and Drug Administration (FDA) approved BiDil (bye-DILL), a drug for the treatment of heart failure in self-identified black patients, representing a step toward the promise of personalized medicine.
The approval of BiDil, marketed by NitroMed, Inc. of Lexington, MA, was based in part on the results of the African-American Heart Failure Trial (A-HeFT). The study, which involved 1,050 self-identified black patients with severe heart failure who had already been treated with the best available therapy, was conducted because two previous trials in the general population of severe heart failure patients found no benefit, but suggested a benefit of BiDil in black patients. Patients on BiDil experienced a 43% reduction in death and a 39% decrease in hospitalization for heart failure compared to placebo, and a decrease of their symptoms of heart failure, according to an FDA release.
Dr. Robert Temple, FDA associate director of Medical Policy states, "The information presented to the FDA clearly showed that blacks suffering from heart failure will now have an additional safe and effective option for treating their condition. In the future, we hope to discover characteristics that identify people of any race who might be helped by Bidil."
BiDil is a combination of two older drugs, neither approved for heart failure--hydralazine and isosorbide dinitrate.