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NitroMed Urges US Approval of Heart Drug for Blacks

GAITHERSBURG, MD
Reuters
June 16, 2005

Blacks should have access to a medicine that sharply cuts deaths from heart failure, manufacturer NitroMed Inc. told a U.S. advisory panel on Thursday as the company urged approval of the first drug for one race of patients.

NitroMed's novel bid to market the drug, BiDil, only for blacks has sparked complaints from some doctors and ethicists who say there is no genetic reason one race should respond differently than others.

The company said its effort is based on solid science and will help fight a disease that strikes blacks more often than others. In a study of 1,050 patients who identified themselves as black, BiDil reduced deaths by 43 percent.

"BiDil, when given to African Americans with heart failure, improves outcomes. In my judgment, this is a benefit we must extend and an opportunity we shouldn't miss," Dr. Clyde Yancy, a NitroMed consultant and professor of medicine at the University of Texas Southwestern Medical Center, told a Food and Drug Administration advisory panel.

The panel of outside experts is considering whether to recommend approval for BiDil, which would be the first drug to reach the market for Lexington, Massachusetts-based NitroMed.

BiDil is a combination of two generic medicines that dilate blood vessels -- isosorbide dinitrate and hydralazine. It was designed to treat congestive heart failure, a progressive weakening that impairs the heart's ability to pump. Half the people diagnosed with heart failure die within five years.

Studies of BiDil in the 1980s did not show a benefit for patients overall, but researchers said blacks fared better than others.

To confirm that finding, NitroMed and the Association of Black Cardiologists studied 1,050 advanced heart failure patients who identified themselves as black, and gave them standard drug therapy plus either BiDil or a placebo.

Deaths were so much lower in the BiDil group that researchers ended the study early so all patients could take BiDil. Fifty-four patients, or 10.2 percent, died in the placebo group, compared with 32 deaths, or 6.2 percent, in the BiDil group.

Some NitroMed critics say the study did not show the drug works better for blacks than others because it did not compare African Americans to patients of other races.

"There's no scientific evidence to support a race-specific approval," Jonathan Kahn, a law professor and ethicist at Hamline University in Minnesota who has studied BiDil's development, said in an interview before the meeting.

NitroMed said it expects a final decision from the FDA on BiDil by June 23. The FDA typically follows the recommendations from its advisory panels.

Trading in NitroMed shares was halted on Nasdaq as the panel met.

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