Jun 16 2005
The U.S. Food and Drug Administration have announced that a heart-failure drug manufactured for African-Americans significantly reduced deaths and hospitalizations and its side effects were similar to those of a placebo's.
The FDA say the drug, BiDil, should be recommended for use in black patients.
This was, according to an FDA staff analysis, the group targeted in the research by drug manufacturer NitroMed.
The development of BiDil has generated controversy as it is the first medicine targeted at a particular race of patients.
The FDA review says that BiDil reduced mortality and the risk of hospitalization because of heart failure in African American patients,and should be indicated in the same population in whom it was studied.
The FDA staff review was released prior to an advisory panel meeting on June 16, where independent experts will decide whether to recommend approval for BiDil.
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