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| |  Canada Approves Enbrel (Etanercept) For Rheumatoid Arthritis TORONTO, ON -- December 8, 2000 -- Health Canada has approved Enbrel® (etanercept) as the country's first biologic therapy for rheumatoid arthritis. Enbrel is approved in adults for reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). In addition, Enbrel can be used in combination with methotrexate in adult patients who do not respond adequately to methotrexate alone. Enbrel vials will be commercially available for use in Canada beginning March 2001 through a patient registry program that is accessible through the patient's rheumatologist. "Enbrel is a breakthrough treatment for Canadians with rheumatoid arthritis," said Aldo Baumgartner, President and Chief Executive Office of Wyeth-Ayerst Canada, Inc. "It brings the hope of effective treatment to many patients for whom existing medications have failed." In a Phase 3 trial of 234 rheumatoid arthritis patients, responses were rapid, often appearing within one to two weeks after initiation of therapy, and nearly always occurred within 3 months. At three months, study results demonstrated that 62 percent of the patients receiving a 25 mg dose of Enbrel reached the primary endpoint of 20 percent improvement by ACR criteria -- a composite score of select measurements of RA symptoms including joint pain, joint swelling, and patient and physician global assessment -- compared to 23 percent of the patients in the placebo group. At 6 months, the secondary endpoints of this study demonstrated a 69 percent median improvement in pain (vs. 2 percent for placebo), a 71 percent median improvement in tender joint counts (vs. 6 percent for placebo), a 51 percent median improvement in swollen joint counts (vs. 2 percent for placebo), and an 88 percent median reduction in duration of morning stiffness (vs. 4 percent for placebo). "Enbrel has given me my life back," says Rebecca McDonald. "Before Enbrel, I could barely get out of bed, let alone climb a set of stairs. Now, I'm able to run up a set of stairs, am active again with my family, and plan to resume my teaching career." Individual responses to Enbrel may vary. In medical studies, Enbrel worked for about two out of three people who used it. In the United States, Enbrel is currently approved as first-line treatment for reducing signs and symptoms and delaying structural damage in patients with moderately to severely active rheumatoid arthritis. Enbrel is also approved for the treatment of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients who have had an inadequate response to one or more disease-modifying medicines. Enbrel is the only TNF inhibitor that can be used with or without methotrexate. In Canada, supplemental applications for polyarticular-course JRA and first-line treatment of moderately to severely active rheumatoid arthritis in adults will be filed soon with Health Canada. "Enbrel works at the source of the inflammation, interrupting the disease cycle and providing rapid and dramatic relief from the painful effects of rheumatoid arthritis," said Dr. Ed Keystone, Director, Centre for Advanced Therapeutics in Arthritis at Mount Sinai Hospital in Toronto, Canada, and a rheumatologist who has been involved in studies of Enbrel. "Treatment with Enbrel has provided these people with new hope -- where there was little before -- to return to a more active and productive lifestyle." Related Links: EnbrelŪ (etanercept) and Wyeth-Ayerst Canada, Inc.
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