NitroMed Inc.’s heart-failure drug for African-Americans reduced deaths and hospitalizations and its side effects were similar to a placebo’s, U.S. regulatory staff said Wednesday.
The drug, BiDil, should be indicated for use in black patients, the group that NitroMed studied, an FDA staff analysis said. BiDil has generated controversy as the first medicine targeted to one race of patients.
NitroMed’s study “has shown that BiDil reduced mortality and the risk of (heart failure) hospitalization in African American heart failure patients,” the review said, adding ”BiDil should be indicated in the same population in whom it was studied.”
The FDA staff review was released ahead of a Thursday advisory panel meeting, where outside experts will decide whether to recommend approval for BiDil.
