SAN DIEGO, Nov. 16 -- Amgen (Nasdaq: AMGN), the world's largest biotechnology company, today announced study results that suggest that Aranesp(R) (darbepoetin alfa) may be administered once monthly in patients with anemia and chronic kidney disease.
This multicenter study enrolled 98 patients with chronic kidney disease receiving Aranesp once every two weeks. Following enrollment, the dosing interval was extended to once monthly by doubling the previous once every 2 week Aranesp dose. Of the 86 patients who completed the study, 85 percent maintained their hemoglobin levels within the target range while receiving Aranesp once monthly. The mean hemoglobin was maintained at 11.1 g/dL following treatment with monthly administration. The cumulative monthly dose requirement was similar when Aranesp was administered once or twice a month.
Adverse events were similar to those reported in previous clinical trials with Aranesp in chronic kidney disease patients. The most common adverse events included hypertension, peripheral edema, fatigue and upper respiratory infection.
Further studies are planned to confirm these findings.
About Aranesp
Aranesp was approved in the U.S. Food and Drug Administration (FDA); most European countries in the European Union, Australia, New Zealand and Canada for the treatment of anemia associated with chronic kidney disease, for patients on dialysis and not on dialysis. The FDA also approved Aranesp(R) for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies.
Aranesp is contraindicated in patients with uncontrolled hypertension. Increases in hemoglobin greater than approximately 1.0 g/dL during any two-week period have been associated with serious side effects. The most commonly reported side effects in Aranesp(R) trials were infection, hypertension, hypotension, myalgia, headache, and diarrhea.
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About Amgen
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
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NOTE TO EDITORS: Copies of the study abstracts are available upon
request. Full prescribing information is available on the Web for Aranesp(R)
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