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|Aranesp Approved for Extended Dosing by European Commission|
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Sept. 20, 2004-- New Dosing Paradigm To Benefit Patients Across EU Suffering From Anemia Associated With Cancer Chemotherapy and Chronic Kidney Disease
Amgen Inc. (Nasdaq:AMGN), the world's largest biotechnology company, today announced that the European Commission has approved expanded marketing authorization for Aranesp(R) (darbepoetin alfa) in the European Union (EU) following the positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) on July 29, 2004. This decision allows extended Aranesp dosing intervals of once-every-three-weeks in the treatment of anemia in adult cancer patients with non-myeloid malignancies who are receiving chemotherapy and up to once-per-month Aranesp administration in the treatment of anemia in chronic kidney disease (CKD) patients not on dialysis.
"This is an important advance for patients, healthcare providers and caregivers across the EU," said Professor Carsten Bokemeyer, Department of Hematology, Oncology and Immunology, Tuebingen University Hospital, Germany. "Aranesp has a unique pharmacokinetic profile compared to conventional rHu-EPO molecules, which means it can be administered less frequently than other erythropoietins. Extended dosing allows healthcare providers to administer Aranesp to adult cancer patients on chemotherapy just once-every-three-weeks, simplifying the treatment process and providing patients the protection they need to manage their anemia."
"Extended dosing makes anemia management in CKD much more convenient," said Fernando Carrera, MD, Eurodial Dialysis Clinic, Leiria, Portugal. "Patients with progressive renal failure often visit their physicians on a monthly basis. Now, the monthly administration of Aranesp can be coordinated with these visits, simplifying anemia management therapy effectively to maximize patient benefits."
Anemia is a common and serious side effect of CKD and cancer chemotherapy. Anemia management with other erythropoietic therapies requires patients to receive treatment more frequently than with Aranesp. As well as consuming the resources of healthcare systems and professionals, this puts a strain on patients themselves who must cope with already demanding treatment regimens. Today's European Commission decision should greatly relieve these burdens.
"Aranesp is the most commonly prescribed erythropoietic treatment for anemia in the EU, and is the first and only erythropoietin approved for every three or four week dosing," said Beth Seidenberg, senior vice president of development and chief medical officer at Amgen. "Patients with grievous illnesses can spend less time in the physicians' office with these new dosing options."
Aranesp was granted marketing authorization by the European Commission in 2001 for the treatment of anemia associated with chronic renal failure in adults and pediatric subjects 11 years of age or older. In 2002, the European Commission approved Aranesp for the treatment of anemia in adult cancer patients receiving chemotherapy with solid tumors. This patient population was subsequently expanded in 2003 to include all adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Important Information About Aranesp
Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events; regional guidelines should be referred to for target and maximum hemoglobin levels, and dose adjustment rules should be performed in line with regional prescribing information.
Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia associated with chronic renal failure, also known as CKD, for patients on dialysis and patients not on dialysis. In July 2002, Aranesp was approved by the FDA for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
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 Amgen's Form 10-K for the year ended December 31, 2003, and in Amgen's 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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CONTACT: Amgen, Thousand Oaks Michael Beckerich, 805-447-4587 (media) Laura Biswas, 805-447-1060 (investors) SOURCE: Amgen Inc.