NitroMed To End Promotion Of Heart Failure Medication

Armen Hareyan's picture

NitroMed has announced plans to end sales andpromotional activities of the congestive heart failure medication BiDil, thefirst medication approved by FDA for use in a specific racial group, althoughthe treatment will remain available to patients, the Wall Street Journalreports (Armstrong, Wall Street Journal, 1/16).

FDA in June 2005 approved BiDil for use in black patients based on the resultsof a clinical trial that found the medication reduced deaths by 43% within oneyear of use among black patients who had taken other treatments. BiDil hasreached about 1% of the 750,000 U.S. blacks with congestive heart failure, inpart because of the high cost of the medication, the availability of anoff-label generic alternative and restrictions under the Medicare prescription drugbenefit (Kaiser Health Disparities Report, 12/14/06).


Analysts had estimated that BiDil would have sales of $130 million in 2006, butthe medication actually registered sales of only $12.1 million that year. Inthe first nine months of 2007, BiDil had sales of $11 million. Jane Kramer,vice president of corporate affairs at NitroMed, said that although more healthinsurers have begun to cover BiDil, the company lacks the capacity to continueto market the treatment. "To keep it going, we need more feet on theground," Kramer said.

Despite the announcement, NitroMed plans to continue the development of a newformulation of BiDil that patients can take one time, rather than three times,daily. NitroMed officials said that the company has received positive reactionfrom FDA on the new formulation of BiDil but added that the medication wouldnot reach the market for several years (Wall Street Journal,1/16).

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