Amgen Statement on U.S. Food and Drug Administration approval of Aranesp® Q2W dosing for de novo correction of anemia in patients with chronic renal failure (CRF)

On May 5, the U.S. Food and Drug Adminstration approved the supplemental biologics license application (sBLA) for Aranesp® (darbepoetin alfa) to expand the indication to include a new dosing regimen of 0.75 mcg/kg once every two weeks (Q2W) for de novo correction of anemia in patients with chronic renal failure (CRF) who are not receiving dialysis. Aranesp was previously approved for de novo QW and maintenance QW and Q2W administration in CRF patients on and not on dialysis.  With this approval, Aranesp is now indicated for either de novo QW or de novo Q2W administration in CRF patients not on dialysis.

We continue to pursue ways to improve the lives of CRF patients, and exploring extended dosing intervals of Aranesp, such as Q2W, is an example of our commitment to these patients. Administration of Aranesp once every two weeks allows physicians and nurses to treat patients with CRF-related anemia more conveniently with fewer office visits.