FDA Recommends Use of Etanercept to Delay Radiographic Progression of Joint Damage in Patients with Early Rheumatoid Arthritis

On April 11, 2000, the U.S. Food and Drug Administrations (FDA) Arthritis Advisory Committee unanimously recommended approval of etanercept (Enbrel037;) for use to delay radiographic progression of joint damage in patients with early rheumatoid arthritis (RA). The advisory committee also recommended approval of etanercept for use in improving signs and symptoms of patients with early stage disease. The committees recommendation for approval was based on results of a phase III randomized, double-blind, multi-center trial that included 632 adults who had RA for less that 3 years and had never received methotrexate therapy. (see ACR meeting highlights-Abstract 280)