On October 18th, an FDA advisory committee voted against changes in the way darbepoetin alfa (Aranesp) is dosed for treating anemia in patients with chronic renal failure who are not on dialysis, based on the results of the TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) study.
Our FDA reporter Elizabeth Mechcatie was there and spoke with Dr. Ajay Singh of Brigham and Women’s Hospital and Dr. Wolfgang Winkelmayer of Stanford University, who had conflicting views about the rescue therapy given to patients in the control arm of the trial. Those in the control group were given rescue therapy with darbepoetin once a month when hemoglobin dropped to below 9 g/dL, and treatment was stopped when hemoglobin increased to 9 g/dL or more. Read her story here.
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