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FDA posts Aranesp briefing documents

October 15, 2010 12:45 AM UTC

FDA posted briefing documents ahead of Monday's Cardiovascular and Renal Drugs Advisory Committee meeting to discuss the Phase III TREAT trial of anemia drug Aranesp darbepoetin alfa from Amgen Inc. (NASDAQ:AMGN) in chronic kidney disease (CKD) patients with Type II diabetes. FDA said the data raise "considerable doubt" about the safety and advisability of using Aranesp to raise the hemoglobin in patients with anemia associated with CKD.

The agency said in addition to failing to demonstrate benefit on either of the primary endpoints, the trial provided evidence that Aranesp increased the risk of stroke and death for those with a prior history of malignancy. The briefing documents also express concern that Aranesp's risk-benefit profile may be more unfavorable than what was observed in TREAT due to the trial's limitations, which FDA said included the exposure of the placebo group to Aranesp, the appropriate selection of the safety population for analysis, the choice of events to include in the primary endpoint, and issues related to statistical power. Last year, Amgen reported that Aranesp missed the trial's two composite co-primary endpoints of time to all-cause mortality or cardiovascular morbidity and time to all-cause mortality or chronic renal replacement therapy vs. placebo. ...