FDA approves Bidil, the first racially-targeted drug

Filed in archive Drugs, Vaccines and Therapeutics on July 10, 2005

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The American Food and Drug Administration approved the drug BiDil on Thursday for the treatment of heart failure in black Americans, calling it a step toward "the promise of personalised medicine." This was mainly based on the results of the African-American Heart Failure Trial (A-HeFT) launched by NitroMed Inc. of Lexington, Mass., involving 1,050 black Americans with severe heart failure. Patients on BiDil experienced a 43% reduction in death and a 39% decrease in hospitalisation for heart failure compared to placebo, and a decrease of their symptoms of heart failure.

This approval may prompt debate, particularly regarding the ethics of using race and other social categories as basis for drug development and medical research.

Dr. Anne Taylor of the University of Minnesota Medical School and a lead investigator in the research of BiDil said, "African-Americans between the ages of 45 and 64 are 2.5 times more likely to die prematurely from heart failure than their non-black counterparts," Such health disparity and the fact that studies DID show higher efficacy in blacks than in the non-black counterparts, suggest that this is not purely a socially and/or politically motivated marketing. The next step would be to identify where the differences lie, and how to broaden its efficacy to other populations.

See the FDA release here.