This article is part of the Arthritis Archives.
Dateline: September 16, 1998
Arava Approved
On September 11, 1998, the U.S. Food and Drug Administration approved Arava, generic name leflunomide, for the treatment of active rheumatoid arthritis in adults.
Rheumatoid arthritis is a chronic autoimmune disease which can lead to deformity and permanent disability. Approximately 2 million Americans are afflicted by rheumatoid arthritis, 70 percent of whom are women.
Arava Trials
Arava (leflunomide) is indicated to reduce signs and symptoms of active rheumatoid arthritis and to retard structural damage as manifested on x-ray as erosion and joint space narrowing. The ability of Arava to slow the progression of rheumatoid arthritis and relieve symptoms was demonstrated in three controlled clinical trials involving more than 1700 patients of whom 800 received Arava. The findings were presented at a meeting of the Arthritis Advisory Committee on August 7, 1998, at which time the committee unanimously recommended approval of Arava. The FDA quickly reviewed and approved Arava following the recommendation.
Efficacy
The efficacy of Arava was demonstrated in:
- measures of tender and swollen joint counts
- physician and patient global assessments
- a function/disability measure
- pain intensity
Arava can be used by patients in both early or advanced stages of rheumatoid arthritis. Early diagnosis and treatment are considered imperative since studies have shown that structural joint damage often begins during the first two years following onset of rheumatoid arthritis.
Special warnings against using Arava exist for pregnant women, pre-menopausal women not using effective birth control, and for people with significant liver disease. Arava will be available in 10 mg., 20 mg., and 100mg. for a 3 day starting dose only. The drug will be marketed by Hoechst Marion Roussel and is expected on pharmacy shelves by mid-October. The average wholesale price will be $8 a day.
Arava is the first new drug in over ten years to be approved for rheumatoid arthritis. Arava will now become an option to the standard treatment for rheumatoid arthritis, methotrexate, which can cause serious side effects and loses effectiveness over time.
Related Resources
Sources: FDA Approves New Arthritis Drug, AP Online, by Lauran Neergaard, 9/11/98; Hoechst Marion Roussel's Arava Approved by FDA, PRNewswire, 9/11/98; FDA Talk Paper, 9/11/1998
First published: 9/16/1998
