The Food and Drug Administration approved the heart drug, BiDil, the first drug in the US designed specifically for African Americans—or any race, for that matter.
The drug hasn’t been without its share of controversy, as critics are leery of race-based medicine.
The African American community, though seem to be behind it. About 750,000 African Americans suffer from heart failure, a much higher rate than among other ethnic groups.
African American heart activists as well as the Association of Black Cardiologists have been behind BiDil’s development since clinical trials shocked researchers by reducing the mortality rate among black patients by 43%. Those of European descent showed little effect.
Lexington, Massachusetts-based NitroMed developed the new medicine, expected to be draw in an estimated $1 billion.
The efficacy of BiDil is thought to be because black patients often have lower levels of nitric oxide, which helps cardiovascular function. A combination of generic isosorbide dinatrate and hydralazine, BiDil increases nitric oxide in the bloodstream.
The new drug is a milestone as it marks the first step toward personalized medicine. Though it is intended for patients who “self identify themselves as black,” the FDA hopes BiDil will be effective for patients of other ethnic backgrounds when used in conjunction with other therapies.
The FDA’s associate director, Robert Temple, said, "In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil."