FDA APPROVES NITROMED HEART DRUG FOR AFRICAN-AMERICANS

The FDA has approved a drug for treating congestive heart failure in African-Americans.

The FDA acted just a week after an agency advisory committee endorsed BiDil, which is manufactured by Massachusetts-based drugmaker NitroMed. Seven of the panel members supported the drug for African-Americans, while two said it should be approved for everyone.

NitroMed's application relied heavily on a clinical trial known as the African-American Heart Failure Trial, or A-HeFT. The study included 1,050 self-identified black patients with severe heart failure. A-HeFT results showed that BiDil patients had a 43 percent reduction in death and a 39 percent decrease in hospitalization for heart failure vs. patients taking a placebo.