NitroMed To End Promotion of Heart Failure Medication Specifically Approved for BlacksNitroMed has announced plans to end sales and promotional activities of the congestive heart failure medication BiDil, the first medication approved by FDA for use in a specific racial group, although the treatment will remain available to patients, the Wall Street Journal reports (Armstrong, Wall Street Journal, 1/16).
FDA in June 2005 approved BiDil for use in black patients based on the results of a clinical trial that found the medication reduced deaths by 43% within one year of use among black patients who had taken other treatments. BiDil has reached about 1% of the 750,000 U.S. blacks with congestive heart failure, in part because of the high cost of the medication, the availability of an off-label generic alternative and restrictions under the Medicare prescription drug benefit (Kaiser Health Disparities Report, 12/14/06).
Analysts had estimated that BiDil would have sales of $130 million in 2006, but the medication actually registered sales of only $12.1 million that year. In the first nine months of 2007, BiDil had sales of $11 million. Jane Kramer, vice president of corporate affairs at NitroMed, said that although more health insurers have begun to cover BiDil, the company lacks the capacity to continue to market the treatment. "To keep it going, we need more feet on the ground," Kramer said.
Despite the announcement, NitroMed plans to continue the development of a new formulation of BiDil that patients can take one time, rather than three times, daily. NitroMed officials said that the company has received positive reaction from FDA on the new formulation of BiDil but added that the medication would not reach the market for several years (Wall Street Journal, 1/16). This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.