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FDA Panel Recommends Arava For Adult Rheumatoid Arthritis KANSAS CITY, MO -- Aug. 10, 1998 -- The United States Food and Drug Administration’s arthritis advisory committee has unanimously recommended the approval of Hoechst Marion Roussel’s Arava(TM) (leflunomide) for the treatment of active rheumatoid arthritis (RA) in adults. If approved, Arava will be the first new disease modifying agent specifically developed for the treatment of rheumatoid arthritis -- a potentially crippling disease that affects more than two million Americans -- in more than a decade. The committee specifically recommended that Arava be approved for relief of signs and symptoms and for retardation of structural damage in RA. In addition, the committee recommended that the FDA consider including language in the labelling regarding improvement in physical function. The recommendations were based in part on a review of pivotal placebo-controlled Phase III clinical trials presented at the meeting. The efficacy of Arava may be a result of its unique mechanism of action that works by reversibly inhibiting an enzyme (DHODH) involved in the autoimmune process that leads to rheumatoid arthritis. "Patients with rheumatoid arthritis need new disease-modifying treatment options because most of the existing therapies lose effectiveness over time and have a high frequency of side effects. Studies have shown Arava to be effective and well tolerated by patients in all stages of disease and that it slows joint deterioration," said Marc Hochberg, M.D., M.P.H., professor of medicine and epidemiology and preventative medicine and the head of the division of rheumatology & clinical immunology at the University of Maryland School of Medicine in Baltimore. "Since studies have shown that structural joint damage often starts during the first two years after disease onset, early diagnosis and treatment are critical. "The availability of a new drug like Arava, that has been used safely and effectively during both early and more advanced disease, would represent a very important step in improving the management of RA." The committee's favourable recommendation, although not binding, will be considered by the FDA in its final review of the New Drug Application (NDA) which was submitted by Hoechst Marion Roussel in March 1998. The FDA placed Arava on a six-month priority review schedule based on the drug's potential therapeutic benefits and the need for new rheumatoid arthritis therapies. Rheumatoid arthritis is one of the most common and severe forms of arthritis. It is a chronic and often debilitating autoimmune disease in which the body's immune system attacks joint tissue, leading to pain, inflammation, deformity and disability that can be permanent. While the cause of RA is not yet known, genetic predisposition plays a role as well as possible hormonal influences and environmental factors such as a bacterial or viral infection triggers. RA generally begins with inflammation (redness, warmth and swelling) in the joints, most commonly the wrist and finger joints closest to the hands, but can also affect the elbows, shoulders, neck, jaw, hips, knees, ankles and feet. In some patients, RA can involve internal organs causing serious damage including inflammation of blood vessels, the lung and the lining surrounding the heart. RA can affect people of all ages, but usually begins in middle age. The disease is approximately three times more common in women than in men. In the U.S., approximately 1.5 million women have RA, representing more than 70 percent of all RA cases. Approximately 50 percent of all RA patients must stop working within 10 years. Arava was generally well tolerated in clinical studies. The most common side effects associated with Arava, which were generally reversible and not severe, included diarrhea, rash, alopecia (transient hair loss) and elevated liver function tests. The committee further recommended that Arava not be used in pregnant women or in patients with significant liver disease. Arava has only been studied in adults. E-mail this page to a friend or colleague! To print, use this version