FDA panel to review heart drug strictly for African-AmericansThis Thursday, an FDA panel will consider whether a previously rejected heart failure treatment called BiDil should become the first drug intended for a particular racial group, in this case African Americans, according to a New York Times report today.
BiDil was denied FDA approval in 1997 after regulators said studies supporting the drug were inconclusive.
The drug's maker, NitroMed, said its decision to test and market the drug now is backed by scientific data. A study of 1,050 African-American heart failure patients showed BiDil significantly reduced death and hospitalization.
But the drug has also 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 regulatory system and patent law, along with historical inequities to drive its product to market, the Times report said.
Investment bank Friedman Billings Ramsey Group told the Times it expects "robust" pricing for the drug and potential annual sales of $825 million based solely on the 750,000 African-American heart failure patients in the U.S.