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Aranesp(R) Administered Once Monthly Maintains Hemoglobin Levels in Patients With Chronic Kidney Disease
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.
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.
Forward Looking Statement
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended December 31, 2002, and in our periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
CONTACT: Amgen, Thousand Oaks Kelly Stoddard, (805) 447-0821 (media) Cary Rosansky, (805) 447-1060 (investors) NOTE TO EDITORS: Copies of the study abstracts are available upon request. Full prescribing information is available on the Web for Aranesp(R) at www.aranesp.com or by calling toll-free 1-800-772-6436. An Electronic version of this news release may be accessed via our Web site at www.amgen.com . Visit the Corporate Center and click on Amgen News. Journalists and media representatives may sign up to receive all news releases electronically at the time of announcement by filling out a short form in the Amgen News section of the Web site.