NitroMed drug cut deaths in blacks
Key points
- 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 on Wednesday.
- The drug, BiDil (hydralazine HCL and isosorbide), should be indicated for use in black patients, the group that NitroMed studied, an FDA staff analysis said.
- 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.
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 on Wednesday.
The drug, BiDil (hydralazine HCL and isosorbide), 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.
Shares of Lexington, Massachusetts-based NitroMed rose 67 cents, or 3.6 percent, to $19.32 in morning trading on Nasdaq.
Written and revised by
Andrey Nailor, M.D.
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