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| |  FDA Approves Arava For Treatment Of Adult Rheumatoid Arthritis KANSAS CITY, MO -- Sept. 11, 1998 -- The United States Food and Drug Administration has approved Hoechst Marion Roussel’s Arava(TM) (leflunomide) for the treatment of active rheumatoid arthritis (RA) in adults. RA is a potentially crippling disease that affects more than two million Americans, 70 percent of them women. Arava is indicated in adults for the treatment of active rheumatoid arthritis to reduce signs and symptoms and to retard structural damage as evidenced by x-ray erosions and joint space narrowing. This marks the first time that a disease-modifying treatment has been indicated for retardation of structural damage in RA based on x-ray analysis. The efficacy of Arava was demonstrated by improvement at endpoint in measures such as tender and swollen joint counts, physician and patient global assessments, a function/disability measure and pain intensity. "Arava can be used by patients in both early and advanced-stage disease and is a significant advance in the treatment of RA," said Dr. Michael Schiff, medical director of the clinical research unit, Denver Arthritis Center. "Studies have shown that structural joint damage often starts during the first two years after disease onset, so early diagnosis and treatment are critical. "Physicians can now offer their patients a drug that not only treats the symptoms of the disease, but that is proven to slow disease progression." Rheumatoid arthritis is one of the most common forms of arthritis and can be severe. It is a chronic and often debilitating autoimmune disease in which the body's immune system attacks joint tissue, leading to pain and inflammation. Often deformity and disability occur and can be permanent. The disease is approximately three times more common in women than in men. In the United States, approximately 1.5 million women have RA, representing more than 70 percent of all RA cases. Approximately 50 percent of all RA patients stop working within 10 years. In clinical studies, the most common side effects associated with Arava included diarrhea, rash, alopecia (transient hair loss) and elevated liver function tests. Arava is contraindicated in pregnant women or in women of childbearing potential who are not using reliable contraception. Arava is not recommended in patients with significant liver disease or hepatitis B or C. Arava has only been studied in adults.
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