The first new disease-modifying agent specifically designed for the treatment of active rheumatoid arthritis in adults in more than a decade will soon be available if the recommendation of the Arthritis Advisory Committee of the U. S. Food and Drug Administration is accepted by the FDA. Arava(TM) (leflunomide) has been developed by pharmaceutical company Hoechst Marion Roussel which "will continue to work closely with the FDA to make Arava available as quickly as possible," comments Gerald P. Belle, president of Hoechst Marion Roussel North America. The committee specifically recommended that Arava be approved for relief of signs and symptoms and for retardation of structural damage in rheumatoid arthritis and has recommended that the FDA consider including language in the labeling regarding improvement in physical function. The effectiveness 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.
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, temporary 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.
According to Marc C. Hochberg, M.D., M.P.H., of the University of Maryland School of Medicine in Baltimore, "Studies have shown Arava to be effective and well tolerated by patients in all stages of disease and that it slows joint deterioration. 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 rheumatoid arthritis."
