AMGEN GETS KEY APPROVAL.Byline: Kristin Reed Bloomberg News Thousand Oaks-based Amgen Inc. won the backing of an expert government panel to expand the uses of its Neupogen immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. drug to include treating patients with a form of leukemia. A Food and Drug Administration advisory committee voted unanimously Friday to recommend that the agency approve the drug for use in patients being treated for Acute Myelogenous Leukemia acute myelogenous leukemia n. Abbr. AML Myelogenous leukemia characterized by rapid abnormal increase in the number of myeloblasts and progression of symptoms. . 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. generally follows the advice of its expert committees. ``It was a well-designed trial and clearly demonstrated effectiveness,'' said Julie Voss, the chairwoman of the panel. The extent of the drug's effect ``was impressive,'' Voss said. Shares of the biotechnology company fell 1 3/16 to 59 15/16. FDA approval for treating low white cell counts in patients with acute myelogenous leukemia would be the fifth approved use for the immune system booster. Acute myelogenous leukemia is a cancer in which the production of abnormal or immature white blood cells White blood cells A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system. Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies crowds out the red platelet blood cells blood cells, n.pl the formed elements of the blood, including red cells (erythrocytes), white cells (leukocytes), and platelets (thrombocytes). blood cells See erythrocyte and leukocyte. Platelets are classed separately. produced in the bone marrow. The chemotherapy and radiation used to treat the condition leave the patient with virtually no immune system. Neupogen has been shown to stimulate the production of healthy immune cells. It has been approved for the prevention of neutropenia Neutropenia Definition Neutropenia is an abnormally low level of neutrophils in the blood. Neutrophils are white blood cells (WBCs) produced in the bone marrow that ingest bacteria. , a low white-blood cell count, in cancer patients whose immune systems have been ravaged rav·age v. rav·aged, rav·ag·ing, rav·ages v.tr. 1. To bring heavy destruction on; devastate: A tornado ravaged the town. 2. by aggressive treatment. An expanded approval of the drug, which had sales of $1 billion in 1996 and makes up about half of Amgen's sales, would be important to the firm as it struggles to maintain its post as the leading biotech company. Last month, Amgen announced it could see slower sales for its other star drug - Epogen - after a government group announced it would reduce Medicare payments for the drug. The new indication for Neupogen would apply to about 10,000 cases a year. If the drug is approved for the new use, sales could increase by between $50 million and $100 million over time. |
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