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