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Drug Development
Supplemental BLA submitted to U.S. FDA for Aranesp extended dosing
June 17th, 2005
Amgen, Inc., (AMGN) submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Aranesp (darbepoetin alfa). The sBLA is based on phase III data that Amgen believes will demonstrate Aranesp administered every 3 weeks is safe and effective in the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. If approved, Aranesp will be the first therapy indicated in the United States for once every 3 week dosing in the treatment of anemia in these patients. "As the first company to clone erythropoietin and develop recombinant EPO as a therapy, Amgen is deeply committed to...
Source: Drug Week (2005-06-17)
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