FDA SENDS APPROVABLE LETTER TO AMGEN FOR EXTENDED DOSING OF ARANESP

Amgen announced that the FDA has issued an approvable letter for Aranesp (darbepoetin alfa) de novo once-every-two-week and maintenance once-monthly dosing regimens for chronic kidney disease patients with anemia not on dialysis.

In 2005, Amgen submitted a biologics license supplement to the FDA for these Aranesp dosing regimens for kidney disease patients with anemia not on dialysis. The FDA has requested more clinical data for the once-monthly dosing regimen, including an additional clinical study. The FDA has also requested additional label language and clarification of submitted data for the de novo once-every-two-week dosing regimen. Amgen said it is committed to working closely with the FDA to resolve these questions in a timely and efficient manner.

Building on the development of Epoetin alfa, Amgen developed Aranesp, a unique erythropoiesis-stimulating protein that can be dosed less frequently. The drug was approved in 2001 for the treatment of anemia associated with chronic renal failure for patients on dialysis and patients not on dialysis. In 2002, Aranesp was approved for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies in the U.S. and the European Union. Today, Aranesp is the only erythropoiesis-stimulating protein approved in the U.S. and EU for weekly and once-every-three-week administration, according to the company.