Health
US Approves First Drug For Specific Racial Group
By Staff
Jun 24, 2005, 11:06

Drug regulators in the US have approved a heart failure drug for African-Americans, the first known medicine of its kind specifically targeted for a racial group.

The US Food and Drug Administration said the approval of the drug BiDil represents a step toward the promise of personalized medicine.

The FDA indicated the approval was based in part on the results of the African-American Heart Failure Trial, which showed African-Americans with severe heart failure experienced a 43 per cent reduction in death and a 39 per cent decrease in hospitalization for heart failure compared to placebo.

"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," the FDA said in a prepared statement.

BiDil is a fixed-dose combination of isosorbide dinitrate and hydralazine hydrochloride. While the exact mechanism of action of BiDil is unknown, it is known that isosorbide dinitrate is a vasodilator with effects on both arteries and veins.

Heart failure affects approximately five million Americans, including an estimated 750,000 African Americans. There is no cure for this disease, and more than 50 per cent of patients die within five years of diagnosis.

BiDil is marketed by NitroMed, Inc. of Lexington, MA.

© Copyright 2004 by HalifaxLive.com