NitroMed scored a first yesterday with US Food and Drug Administration approval of its heart failure drug, BiDil (isosorbide/hydralazine), as the first treatment available specifically for black patients - a group that is more than twice as likely to suffer from heart failure than whites.
In a statement released after the stock markets closed last night, the FDA said that the drug’s approval represented “a step toward the promise of personalised medicine.” The FDA is keen to encourage the development of “personalised medicines” through the field of science known as pharmacogenomics, which is sees as a sort of Holy Grail for medicines research, and earlier this year launched new guidelines in a bid to speed up the development process [[23/03/05b]].
Dr Robert Temple, the FDA’s associate director of medical policy said: “[This] approval of a drug to treat severe heart failure in self-identified black population is a striking example of how a treatment can benefit some patients even if it does not help all patients… 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.”
Approval was based on data from the A-HeFT clinical trial, which showed that black patients treated with BiDil experienced a 43% decrease in the risk of mortality and a 39% reduction in the risk of first hospitalisation from heart failure compared to placebo, and a decrease of their symptoms of heart failure. A-HeFT was the first clinical study conducted in a heart failure population in which all of the participants identified themselves as black.
“FDA approval of BiDil represents an important leap forward in addressing this health disparity,” said Anne Taylor, associate dean for faculty affairs, professor of medicine, University of Minnesota Medical School and lead A-HeFT investigator.