Hotline Archive - Preliminary FDA Approval of Arava (leflunomide)
August 1998
Patient Information
Arava® was reviewed and approved by the FDA’s Arthritis Advisory Committee for the treatment of adult rheumatoid arthritis on Friday, August 7, 1998. This drug is the first in a new class of DMARDs (disease-modifying anti-rheumatic drugs) to be reviewed by the FDA for the treatment of RA. It inhibits at least one enzyme in lymphocytes (cells of the immune system) and thus interferes with the RA disease process.
In clinical trials, Arava showed significant improvement in RA signs and symptoms and demonstrated slowing of joint damage. Patients may experience diarrhea or – rarely – liver problems, hair loss, rash or hypertension. At this time, Arava is not recommended for children or women who are pregnant or nursing.
The committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of Arava in September.
August 11, 1998
Nancy Lane, MD
Elliott Rosenstein, MD
Co-editors, ACR Hotline
The Hotline is provided by the American College of Rheumatology Communications and Marketing Committee as an information service to members. This Hotline does not represent a position statement of the College.
