Darbepoetin Alfa

Trade name: Aranesp

Manufacturer: Amgen Inc., Thousand Oaks, CA

Indications: Treatment of anemia associated with chronic renal failure, including patients on dialysis or not on dialysis

Approval date: 17 September 2001

Type of submission: Biologics license application

A. General description Darbepoetin alfa is an erythropoiesis-stimulating protein, closely related to erythropoietin, that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin is a 165 amino-acid protein that differs from recombinant human erythropoietin in containing five N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains three. The two additional glycosylation sites result from amino-acid substitutions in the erythropoietin peptide backbone. The additional carbohydrate chains increase the molecular weight of the glycoprotein from 30,000 to 37,000 daltons.

B. Indications and use Aranesp is indicated for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.

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