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| |  Enbrel Approved In Europe For Rheumatoid And Juvenile Arthritis MADISON, NJ -- February 7, 2000 -- Wyeth-Ayerst Pharmaceuticals, the pharmaceutical division of American Home Products Corporation announced that the rheumatoid arthritis treatment Enbrel (R) (etanercept) has been cleared for marketing in the 15 European Union countries by the European Medicines Evaluation Agency (EMEA) for the treatment of active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate, has been inadequate. The EMEA has also approved Enbrel in the treatment of polyarticular course juvenile chronic arthritis (JCA). The approval comes after a positive opinion in November 1999 from the Committee on Proprietary Medicinal Products (CPMP).
"Since being launched in the United States in November 1998, Enbrel, a significant therapeutic breakthrough in the treatment of rheumatoid arthritis, has become a well-accepted therapy by rheumatologists with more than 50,000 patients using Enbrel," according to Harold Marder, M.D., Senior Vice President, Global Medical Director, Wyeth-Ayerst Pharmaceuticals. "When Enbrel was approved in the U.S. it represented the first innovation in treating rheumatoid arthritis in more than 15 years. Physicians report dramatic symptomatic relief with Enbrel for some of their most severe rheumatoid arthritis cases." Enbrel was discovered by Immunex, a Seattle-based biopharmaceutical company and jointly developed with Wyeth-Ayerst. The two companies co-promote Enbrel in North America, and Wyeth-Ayerst will market Enbrel outside of North America. The U.S. Food and Drug Administration (FDA) approved Enbrel for the treatment of rheumatoid arthritis in November 1998. In May 1999 the FDA approved Enbrel for the treatment of juvenile rheumatoid arthritis. Enbrel will be introduced in Europe in a staged manner. All current users enrolled in pre-approval named patient programs will continue to have uninterrupted access to Enbrel. As previously announced, because of the rapid and favorable market acceptance of Enbrel by both patients and physicians, American Home Products and Immunex are Enbrel a substantial investment to increase production capacity. As manufacturing expansion efforts progress, additional product will be made available worldwide. In clinical studies involving more than 1,800 rheumatoid arthritis patients, ENBREL use demonstrated improvement in the number of tender joints and the number of swollen joints in patients with severe disease who had previously failed to respond to conventional therapies. Measurements of health-related functionality, as well as patient mental health and vitality also improved with ENBREL treatment. The first in a new class of rheumatoid arthritis drugs known as biologic response modifiers, Enbrel is an entirely novel approach to the management of rheumatoid arthritis. Enbrel acts by binding tumor necrosis factor (TNF). TNF is one of the dominant cytokines or proteins in the cascade of reactions that cause the inflammatory process of rheumatoid arthritis. Enbrel is a synthesized version of the human TNF receptor. Each Enbrel molecule contains two copies of the active portion of the native TNF receptor. ENBREL acts directly on TNF by capturing it before it can bind to the TNF receptor sites on cells. The binding of Enbrel to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity. Enbrel should not be started in the presence of sepsis, infection (including chronic or localized), or allergy to Enbrel or its components. Physicians should use caution in patients predisposed to infection. Enbrel should be discontinued in patients with serious infections or sepsis. Patients should be closely monitored for new infections during Enbrel treatment. In post marketing use, serious infections including sepsis and death have been reported. Long-term effects of Enbrel on the development or course of infections, malignancy, and autoimmune disease are unknown. The most frequent adverse events in clinical trials were injection site reactions (37 per cent), infections (35 per cent) and headache (17 per cent). Malignancies were rare (less than 1 per cent). Only the rate of injection site reactions was significantly higher than placebo. Related Links: Enbrel (etanercept), Wyeth-Ayerst Pharmaceuticals and American Home Products Corporation.
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