October 19th, 2010
FDA Advisors Recommend No Changes for Aranesp
The FDA Cardiovascular and Renal Advisory Committee has endorsed the status quo for Aranesp (darbepoetin alfa). The committee met on Monday to discuss the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) and voted 15-1-1 against withdrawal of the indication for chronic kidney disease (CKD) patients not on dialysis. The committee also voted against adoption of the control arm of TREAT (rescue darbepoetin alfa when hemoglobin dropped below 9 g/dl) as the indication for the drug and said that the drug did not require further restrictions against use in dialysis patients or in patients with CKD with a history of stroke.