2005-06-25

Feu vert FDA pour commercialisation du BiDil de Nitromed

FDA OKs Nitromed's heart drug for African-Americans

By Val Brickates Kennedy
Last Updated: 6/24/2005 3:25:43 PM


BOSTON (MarketWatch) - The Food and Drug Administration has formally approved Nitromed's drug BiDil for the treatment of heart failure in African-Americans, making it the first drug approved in the U.S. to treat a specific racial group.

Nitromed (NTMD)said late Thursday night the agency had formally approved BiDil for the treatment of "self-described black patients." The drug will be used in conjunction with other standard heart therapies.

The company had sought approval of the drug to treat patients of African descent after clinical trials had shown the drug to be highly effective in that ethnic group. The same trials had also found the drug to be largely ineffective in the rest of the population.

Nitromed shares were halted early Friday and were still halted by late afternoon.

Medical experts believe that BiDil is effective in black patients because they often have lowered levels of the compound nitric oxide, which aids in cardiovascular function. BiDil, a combination of the generic drugs isosorbide dinitrate and hydralazine, enhances nitric oxide in the bloodstream.

According to Nitromed, about 750,000 African-Americans have heart failure in the U.S. African-Americans are known to suffer from the disease in much greater numbers than other ethnic groups and often don't respond as well to standard cardiac medications.

Because of this, BiDil has enjoyed considerable support from African-American health activists and the Association of Black Cardiologists, which co-sponsored some of the drug's clinical trials.

According to Pacific Growth Equities analyst Liana Moussatos, the company could launch the drug in about four weeks. She estimated BiDil will have 2006 sales of $83.9 million, based on a late September 2005 launch.

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