Arava committee review
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Aventis' rheumatoid arthritis therapy Arava (leflunomide) should be approved for an improvement in physical function claim, FDA's Arthritis Drugs Advisory Committee recommends March 5 (11-0, two abstentions). Aventis conducted one-year extension studies of its three NDA pivotal trials that showed continued improvements over placebo on the Health Assessment Questionnaire. Committee also agrees that a stronger liver toxicity warning in labeling and a related "Dear Doctor" letter are not necessar
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Arava physical function claim, liver toxicity warning
FDA approves Aventis' rheumatoid arthritis agent Arava (leflunomide) for improvement of physical function in RA patients. The June 13 approval also updates labeling to include a bolded warning on severe liver injury and more explicit monitoring instructions. The update is in contrast to the March 5 Arthritis Drugs Advisory Committee's recommendation that the agent's previous liver toxicity warning was sufficient. The committee voted 11-0 (two abstentions) for approval of the physical function claim (1Pharmaceutical Approvals Monthly March 1, 2003, In Brief)...
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