FDA approves first ethnically targeted drug
The agency called the approval "a step toward the promise of personalized medicine."
FDA associate director of medical policy Robert Temple said in a statement that the approval "is a striking example of how a treatment can benefit some patients even if it does not help all patients."
As reported at www.mmm-online.com, an FDA advisory panel recommended that the agency approve the drug last week.
The push to market the BiDil has raised questions about how marketing, regulatory and political considerations play a role in new drug development, with critics of NitroMed saying the company has managed the system and patent law, along with historical inequities, to drive its product to market.
NitroMed, said its decision to test and market the drug now is backed by a study of 1,050 African-American heart failure patients that showed BiDil significantly reduced death and hospitalization.
Analysts expect that potential annual domestic sales of BiDil could reach $825 million based on the 750,000 African-American heart failure patients in the U.S.