AMGEN SUBMITS ANEMIA THERAPY VARIATION APPLICATION TO EMEA.Amgen (Nasdaq:AMGN), Thousand Oaks, Calif., has submitted a variation application to the European Agency for the Evaluation of Medicinal Products (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) to expand the clinical indication for Aranesp(TM) (darbepoetin alfa darbepoetin alfa Aranesp Pharmacologic class: Recombinant human erythropoietin Therapeutic class: Hematopoietic Pregnancy risk category C FDA Boxed Warning), its new anemia therapy. The new indication sought is for the treatment of anemia associated with chemotherapy for cancer patients. Throughout Europe, between 50 percent and 60 percent of patients with cancer undergoing chemotherapy may be anemic. Data have shown that only one-tenth of these patients are treated for their anemia with an erythropoietic ErythropoieticReferring to the creation of new red blood cells. Mentioned in: Porphyrias erythropoietic emanating from or pertaining to erythropoiesis. agent. "This is an important milestone for Amgen demonstrating our ongoing commitment to improved therapies for cancer patients and their caregivers. Aranesp may provide both chemotherapy patients and caregivers the power to simplify anemia management," said Roger Perlmutter, Amgen's executive vice president for Research & Development. According to Robert Pirker, M.D., of the University of Vienna History The University was founded on March 12, 1365 by Duke Rudolph IV and his brothers Albert III and Leopold III, hence the additional name "Alma Mater Rudolphina". After the Charles University in Prague, the University of Vienna is the second oldest university in Central Medical School and lead investigator of Amgen's pivotal oncology study, "Our clinical data confirm that Aranesp is a powerful, fast-acting erythropoiesis erythropoiesis /eryth·ro·poi·e·sis/ (-poi-e´sis) the formation of erythrocytes.erythropoiet´ic e·ryth·ro·poi·e·sis n. The formation or production of red blood cells. stimulating protein with the added benefit of less-frequent dosing. I expect more patients to receive this drug because it requires fewer injections than existing therapies." Aranesp was recently approved by the EMEA and the U.S. Food and Drug Administration for the treatment of anemia associated with chronic renal failure chronic renal failure Chronic kidney failure Nephrology A slow decline in renal function, which may be 2º to chronic HTN, DM, CHF, SLE, or sickle cell anemia and, if extreme, leads to ESRD, mandating kidney dialysis; an abrupt decline in renal function may be , including patients on dialysis and patients not on dialysis. Due to the longer serum half-life, Aranesp should be administered to chronic renal failure patients less frequently than Epoetin alfa e·po·e·tin al·fa n. A recombinant preparation of human erythropoietin used to treat some forms of anemia. epoetin alfa Epogen, Eprex (CA) (UK), Procrit Pharmacologic class: , thus, simplifying anemia management for patients and healthcare providers. Aranesp is approved for subcutaneous or intravenous administration once per week, with some patients being treated successfully with Aranesp administered once every two weeks. Aranesp should be administered once every two weeks in patients currently receiving Epoetin alfa once per week. Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology. For more information, call 805/447-3227. |
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