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| |  FDA Advisory Committee Recommends Enbrel For Rheumatoid Arthritis GAITHERSBURG, MD -- Sept. 17, 1998 -- The United States Food and Drug Administration’s arthritis advisory committee has recommended the approval of Immunex Corp.’s Enbrel(TM) (etanercept) for the treatment of active rheumatoid arthritis (RA). If approved, the drug will be the first entirely new approach to treating RA approved in the last 15 years. The FDA advisory committee recommended that Enbrel be approved for use alone in patients who have failed other so-called disease modifying anti-rheumatic drugs (DMARDs). In addition, the committee recommended that Enbrel be approved for use in combination with methotrexate. Enbrel has been studied in 1,039 RA patients. Clinical results presented by Immunex demonstrated greater reduction in joint pain and swelling in patients receiving Enbrel, compared with patients receiving placebo. Measurements of health-related quality of life, including functionality, mental health and vitality also improved with Enbrel treatment. Many patients reported responses to Enbrel within weeks after initiation of therapy. The most common side effect observed was mild injection-site reactions that generally did not interrupt treatment. "The data show that Enbrel provides relief of symptoms for many RA patients, many of whom have not been treated successfully with other drugs or cannot tolerate the side effects associated with some current medications," said Larry Moreland, MD, division of immunology and rheumatology, University of Alabama at Birmingham. More than 100 patients have been treated with Enbrel for at least 15 months and more than 80 percent of them experienced relief of their symptoms, which was sustained. Clinical studies showed that patients have responded to Enbrel even after other therapies failed and that Enbrel can be given in combination with methotrexate, without increasing side effects. Longer term studies with Enbrel are ongoing and will continue to expand the drug’s database. Enbrel acts by binding, or capturing excess TNF. TNF is one of the dominant cytokines or proteins that play an important role in the cascade of reactions that cause the inflammatory process of RA. Enbrel competitively inhibits the binding of TNF molecules to TNF receptor (TNFR) sites. By preventing TNF from binding to TNFR sites, Enbrel renders the cytokine inactive, resulting in reduced inflammatory activity. Rheumatoid arthritis is a chronic and potentially disabling disorder that affects 2.1 million -- or one in 100 -- Americans. It is a serious systemic rheumatic disorder that causes the body's immune system to attack the lining of the joints, resulting in pain and swelling and may lead to fatigue, disability, deformity, organ damage, or premature death if not managed effectively.
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