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

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

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. 


 
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