FDA Set to Approve Heart Treatment Specific to African Americans

The FDA has said it is prepared to approve BiDil, a drug designed to treat heart failure in African-American patients, in what would be the first approval of a treatment "specifically developed for a black patient population with a disease common among the general population," the Wall Street Journal reports. According to Bedford, Mass.-based NitroMed Inc., which developed the drug, the FDA has sent the company a "so-called approvability letter" for BiDil, although NitroMed would still have to conduct a clinical trial exclusively on a group of African-American men and women before receiving final approval, company officials said. NitroMed developed the drug -- a combination of isosorbide dinitrate, an angina medicine, and hydralazine, a diuretic used to treat high blood pressure -- after a 1999 study revealed that the combination "proved effective" in improving heart failure survival among African-American patients, while offering "little benefit" to whites. The company said the drug works by restoring levels of nitric oxide, which has a "beneficial action" in blood-vessel walls and is more likely to reach depleted levels in blacks than in whites -- a difference that may explain why blacks are more responsive to the drug (Winslow, Wall Street Journal, 3/9).