Amgen Submits sBLA for Aranesp Extended Dosing

Amgen has submitted a supplemental biologic license application (sBLA) to the FDA for Aranesp.

The sBLA is based on Phase III data that Amgen believes will demonstrate Aranesp administered every three weeks is safe and effective in the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.

If approved, Aranesp (darbepoetin alfa) will be the first therapy indicated in the U.S. for once-every-three-week dosing in the treatment of anemia in these patients, the company said.