FDA Approves Amgen’s Aranesp for Anemia of Chronic Renal Failure

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 10 No 10
Volume 10
Issue 10

ROCKVILLE, Maryland-The FDA has approved Amgen’s Aranesp (darbepoetin alfa) for Injection for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.

ROCKVILLE, Maryland—The FDA has approved Amgen’s Aranesp (darbepoetin alfa) for Injection for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.

Due to its longer serum half-life, Aranesp requires fewer injections than the existing treatment epoetin alfa (Epogen, Procrit), Amgen said in a media release. The recommended starting dose is 0.45 µg/kg given intravenously or subcutaneously once weekly. Some patients have been treated successfully with SC Aranesp once every 2 weeks.

When converting from epoetin alfa, Aranesp should be given once a week if a patient was receiving epoetin alfa 2 to 3 times weekly, and once every 2 weeks if a patients was on epoetin alfa once weekly.

Approval was based on data from 1,598 patients with chronic renal failure treated in 12 clinical trials. Patients receiving Aranesp consistently reached target hemoglobin levels.

Amgen has filed a supplemental biologics license application for Aranesp for the treatment of cancer patients with chemotherapy-related anemia. 

Related Videos
Investigators must continue to explore the space for lisocabtagene maraleucel in mantle cell lymphoma, according to Manali Kamdar, MD.
Those with CML should discuss adverse effects such as nausea or fatigue with their providers to help optimize their quality of life during treatment.
A panel of 4 experts on multiple myeloma
A panel of 4 experts on multiple myeloma
Patients with CML can become an active part of their treatment plan by discussing any questions that come to mind with their providers.
A panel of 4 experts on multiple myeloma
Video 1 - 4 KOLs are featured in "Treating Patients Referred to Academic Centers for CAR T"
Video 1 - 4 KOLs are featured in "Identifying Potential Candidates for CAR T-Cell Therapy"
Beth Faiman, CNP, PhD, an expert on multiple myeloma
Related Content