Panel Recommends Keeping Aranesp for Kidney Disease Patients Not on Dialysis

The FDA’s Cardiovascular and Renal Drugs Advisory Committee has voted overwhelmingly to recommend keeping Amgen’s Aranesp available to treat anemia associated with chronic renal failure in patients not on dialysis. The committee voted 15–1 Monday against withdrawing Aranesp’s (darbepoetin alfa) approval in non-dialysis patients. Several panelists advised Aranesp could be particularly beneficial for certain subpopulations, such as patients with low hemoglobin.
Drug Industry Daily