Canada
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Health Canada Approves ENBREL(R)etanercept) for the Treatment of ModeratelyTo Severely Active Rheumatoid Arthritis Canada's First Biologic Therapy for Rheumatoid Arthritis Provides New Treatment Option for Patients TORONTO, Dec. 8 /PRNewswire/ -- Health Canada has approved ENBREL(R) (etanercept) for use in Canada. As Canada'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." About Rheumatoid Arthritis According to the Arthritis Society of Canada, nearly 300,000 Canadians have rheumatoid arthritis -- the most disabling form of arthritis that causes pain, swelling, and severe limitations of movement that can lead to disability. Joint inflammation can destroy cartilage, tendons and ligaments, wear away bone and subsequently cause joint deformity. People with rheumatoid arthritis live on average 10 years less than those who do not suffer from rheumatoid arthritis. Rheumatoid arthritis can affect people at any age, but most commonly people ages 25 to 50. Women are three times more likely than men to develop the disease. ABOUT ENBREL ENBREL acts by binding tumor necrosis factor (TNF). TNF is one of the dominant cytokines or proteins that play an important role in normal immune function and the cascade of reactions that cause the inflammatory process of RA. ENBREL competitively inhibits binding of TNF molecules to the TNF receptor (TNFR) sites. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity. SINCE THE PRODUCT WAS FIRST INTRODUCED, SERIOUS INFECTIONS, SOME INVOLVING DEATH, HAVE BEEN REPORTED IN PATIENTS USING ENBREL. MANY OF THESE EVENTS OCCURRED IN PATIENTS WHO WERE PRONE TO INFECTIONS, SUCH AS THOSE WITH ADVANCED OR POORLY CONTROLLED DIABETES. ENBREL SHOULD BE DISCONTINUED IN PATIENTS WITH SERIOUS INFECTIONS. DO NOT START ENBREL IF YOU HAVE AN INFECTION OF ANY TYPE OR IF YOU HAVE AN ALLERGY TO ENBREL OR ITS COMPONENTS. ENBREL SHOULD BE USED WITH CAUTION IN PATIENTS PRONE TO INFECTION. There have been rare reports of serious nervous system disorders such as multiple sclerosis and/or inflammation of the nerves of the eyes. Tell your doctor if you have ever had any of these disorders or if you develop them after starting ENBREL. There have also been rare reports of serious blood disorders, some involving death. Contact your doctor immediately if you develop symptoms such as persistent fever, bruising, bleeding or paleness. It is unclear if ENBREL has caused these nervous system or blood disorders. If your doctor confirms serious blood problems, you may need to stop using ENBREL. The most frequent adverse events in placebo-controlled clinical trials involving 349 adults were injection site reactions (ISR) (37%), infections (35%), and headache (17%). Only the rate of ISR was higher than that of placebo. The most frequent adverse events in a methotrexate-controlled clinical trial of 415 adults with early-stage RA were infections (64%), ISR (34%), and headache (24%). Only the rate of ISR was higher than that of methotrexate. In all 1,197 RA patients studied, malignancies were rare (1%). In a study of 69 patients with JRA, infections (62%), headache (19%), abdominal pain (19%), vomiting (13%), and nausea (9%) occurred more frequently than in adults. The types of infections reported in JRA patients were generally mild and consistent with those commonly seen in children. Serious adverse reactions reported rarely were chicken pox (3%), gastroenteritis (3%), depression/personality disorder (1%), skin ulcer (1%), inflammation in parts of the upper digestive tract (1%), group A streptococcal septic shock (1%), type I diabetes mellitus (1%), and soft tissue and post-operative wound infection (1% each). Immunex Corporation and Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, market ENBREL in North America. Other AHP affiliates will market ENBREL outside of North America. Immunex manufactures and records sales of ENBREL in the United States and Canada. Additional information about ENBREL, including the U.S. full prescribing information, can be found on the company-sponsored website at (www.enbrel.com) or by calling toll-free 888-4ENBREL (888-436-2735). Immunex Corporation is a leading biopharmaceutical company dedicated to improving lives through immune system science innovations. American Home Products Corporation's Wyeth Ayerst division is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines, oncology and hemophilia products and generic pharmaceuticals. American Home Products Corporation is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of prescription drugs and over-the-counter medications. It also is a global leader in vaccines, biotechnology and animal health care. NOTE: This news release contains forward-looking statements that involve risks and uncertainties, including risks associated with clinical development, regulatory approvals, our reliance on third-party manufacturers, product commercialization and other risks described from time to time in the SEC reports filed by Immunex, including the most recently filed Form 10-Q. An electronic version of this news release -- as well as additional information about Immunex of interest to investors, customers, future employees and patients -- is available on the Immunex home page at www.immunex.com. SOURCE Immunex Corporation CO: Immunex Corporation; Health Canada ST: Washington, Ontario IN: MTC BIO SU: 12/08/2000 08:00 EST http://www.prnewswire.com |
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