Amgen Submits Aranesp™ License Supplement To European Agency For The Treatment Of Anemia Associated With Chemotherapy
THOUSAND OAKS, Calif., October 23, 2001 -- Amgen announced it had submitted a variation application to the European Agency for the Evaluation of Medicinal Products (EMEA) to expand the clinical indication for Aranesp™ (darbepoetin alfa), 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 has shown that only one-tenth of these patients are treated for their anemia with an erythropoietic 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 Medical School and lead investigator of Amgen's pivotal oncology study, "Our clinical data confirms that Aranesp is a powerful, fast-acting erythropoiesis 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, 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, 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.
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