AMGEN'S ANTI-ANEMIA DRUG GETS BOOST.Byline: Jesse Hiestand Staff Writer THOUSAND OAKS - Amgen Inc. said Monday that its new anti-anemia drug has cleared the main hurdle for European approval and could be on the market both there and in the United States by summer. Aranesp was submitted to regulators in Europe and America in December 1999, two years after initial tests were undertaken. Backlogs in drug approvals have the U.S. Food and Drug Administration running about six months behind its goal of getting reviews finished in a year, or six months if the drug is the first of its kind. ``We're just waiting for an answer,'' said Amgen spokesman Michael Beckerich. ``It could be any day now for the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. .'' In the meantime Adv. 1. in the meantime - during the intervening time; "meanwhile I will not think about the problem"; "meantime he was attentive to his other interests"; "in the meantime the police were notified" meantime, meanwhile , the European Committee on Proprietary Medicinal Products has considered Aranesp's safety and effectiveness and recommended its approval to the European Commission, which could give final marketing authorization in as little as 90 days. Amgen's stock closed at $64.25 on the Nasdaq on Monday, up $1.88, or 3 percent. Aranesp is a next-generation version of the company's flagship Epogen, for anemia stemming from kidney disease Kidney Disease Definition Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease. . Epogen accounts for 95 percent of the company's sales, which hit $3.4 billion in 2000. Where Epogen is used at the end stage of renal disease Renal disease Kidney disease. Mentioned in: Glycogen Storage Diseases hypertension High blood pressure Cardiovascular disease An abnormal ↑ systemic arterial pressure, corresponding to a systolic BP of > 160 mm Hg , Aranesp can be used throughout chronic kidney disease Chronic kidney disease (CKD), also know as chronic renal disease, is a progressive loss of renal function over a period of months or years through five stages. Each stage is a progression through an abnormally low and progressively worse glomerular filtration rate, which is and requires less dosage. Later this year, Amgen plans to seek FDA approval to use it to fight cancer-related anemia. ``Aranesp gives doctors and patients flexibility with their dosings,'' Beckerich said, adding that that translates into fewer doctor visits, paperwork and needles. Aranesp stimulates bone marrow to make more red blood cells Red blood cells Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body. Mentioned in: Bone Marrow Transplantation red blood cells , which bring about anemia when they fall below normal levels. Epogen was the subject of a four-year court battle between Amgen and Transkaryotic Therapies Inc. of Cambridge, Mass. Amgen, which sued for patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. , won the suit in January. Once approved, Aranesp could be on the market within weeks. Launch schedules for each European Union country vary according to the nation's pricing and reimbursement procedures. Applications for the drug were filed in early 2000 in Canada, New Zealand and Australia. |
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