Farmanews.com

Notas de Prensa  

16 de noviembre de 2003

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.

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.

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.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company´s results may be affected by our ability to successfully market both new and existing products domestically and internationally, sales growth of recently launched products, difficulties or delays in manufacturing our products, and regulatory developments (domestic or foreign) involving current and future products and manufacturing facilities. In addition, sales of our products are affected by reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible US legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of our product. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We, or others could identify side effects or manufacturing problems with our products after they are on the market. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. Further, some raw materials, medical devices, and component parts for our products are supplied by sole third party suppliers.

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.

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.

Subir  

Subir notas de prensa y convocatorias

Próximas convocatorias   


Ver todas

Especialidades  

Busca notas de prensa por especialidad médica o enfermedad.



Ver todas

Archivo  

Busca notas de prensa por su fecha de edición.

  Selecciona el año


Copyright © 2017, Farmavet, S.L. Todos los derechos reservados.