Drug for specific race gets first-round OK
Associated Press | June 17, 2005
WASHINGTON — Government advisers on Thursday recommended approval of what could be the first drug aimed at a specific racial group.
The Food and Drug Administration's cardiovascular drug advisory panel voted 9-0 in favor of allowing sales of the heart failure drug BiDil.
A clinical trial of the drug in black Americans was halted early when it became apparent that those using the drug did better than those not using it.
That trial, on just over 1,000 individuals, was launched after the FDA turned away the drug following a study involving all races that showed little improvement — but also gave hints that black patients might have had some benefit.
The maker, NitroMed of Lexington, Mass., then decided on a trial using blacks only, a population that has more than twice the rate of heart failure as whites.
In heart failure, the heart is too weak to beat effectively and fluid builds up in the lungs. As many as half of all victims die within five years.
The usual treatment is with drugs called ACE inhibitors, but research has indicated they do not work as well in black patients as in white patients.
BiDil is a combination of two drugs: hydralazine, which eases blood pressure, and isosorbide dinitrate, which is used for heart pain. The combination also boosts the amounts of nitric oxide in the blood, a substance that is found in lower levels in blacks.