U.S. Panel Backs Nitromed Heart Drug for Blacks

GAITHERSBURG, Maryland (Reuters) - The first medicine for patients of one particular race moved closer to U.S. approval on Thursday after an advisory panel endorsed a NitroMed Inc. heart failure pill for blacks.

NitroMed's novel bid to market the drug, BiDil, only for black patients sparked complaints from some doctors and ethicists who said there was no biological reason one race should respond differently than others.

But seven out of nine members of a Food and Drug Administration advisory panel said the drug should be cleared for use only in blacks because that was the group NitroMed studied, and the benefits were convincing. Many praised NitroMed for focusing on a group they said needed more attention in medical research.

"This was a courageous thing to do for a population that has a disproportionate burden of disease ... As a clinician, I find the evidence more than adequate for approval," said Dr. Steven Nissen, a Cleveland Clinic cardiologist and the panel's chairman.

African-Americans are more likely than others to develop heart failure and to die early from the disease, studies have found. In NitroMed's trial of 1,050 patients who identified themselves as black, BiDil reduced deaths by 43 percent.

If the FDA takes the panel's advice, which it usually does, BiDil would be the first drug to reach the market for Lexington, Massachusetts-based NitroMed.

An approval specifically for blacks would benefit NitroMed because the company holds patent rights for that use until 2020. The patent for BiDil for general use expires in 2007.

Even with an approval for blacks only, doctors could prescribe BiDil for anyone they thought it might help.

Some critics of NitroMed's plan said they felt BiDil would work in some people of other races or ethnic backgrounds and therefore should be approved for general use. Some of the critics argue that in the past, some drugs were studied only in white people but their approved uses were not limited.

"I don't find any justification for approving it only in one particular patient population," said Dr. Ronald Portman, a panel member and pediatric nephrologist at the University of Texas-Houston Medical School. Portman was one of two panelists who backed BiDil's approval but opposed singling out blacks.

"I think it was a very positive outcome," Jennifer Chao, an analyst with Deutsche Bank, said of the panel recommendation. Ahead of the meeting, Chao predicted annual BiDil sales would hit $270 million in 2008.

BiDil is a combination of two generic medicines -- isosorbide dinitrate and hydralazine -- that dilate blood vessels. It was designed to treat congestive heart failure, a progressive weakening that impairs the heart's ability to pump. About 750,000 African-Americans have been diagnosed with heart failure, NitroMed said. Half the people with heart failure die within five years of diagnosis.

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

NitroMed and the Association of Black Cardiologists then 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.

NitroMed said it expects a final decision from the FDA by June 23. Trading in the company's shares was halted on Nasdaq during the panel meeting.