ARTICLE | Product Development

'Race as a surrogate'

June 20, 2005 7:00 AM UTC

Last week's meeting of the Cardiovascular and Renal Drugs Advisory Committee sets the stage for the FDA's first race-based drug approval. The committee's consensus that NitroMed Inc.'s BiDil combination of isosorbide dinitrate and hydralazine hydrochloride should be indicated only for people who identify themselves as black elicited condemnation from some African-American medical groups. It is, however, a logical outcome of the government's longstanding requirements to make race a major factor in clinical research, according to Robert Temple, director of FDA's Office of Drug Evaluation I.

FDA approval would end a two-decade odyssey for BiDil. Researchers began testing the combination of generics to treat heart failure in the 1980s. Isosorbide dinitrate is a nitric oxide donor that has been approved to treat angina since 1959. Hydralazine is an antioxidant and vasodilator approved for hypertension. ...