Abbott Laboratories announced that it has received US Food and Drug Administration (FDA) approval to market Humira® (adalimumab), its tumor necrosis factor (TNF)-blocking fully human monoclonal antibody, for first-line treatment of recent-onset moderate-to-severe rheumatoid arthritis (RA). The European Medicines Agency (EMEA) approved Humira in August 2005 for marketing in Europe for the treatment of early severe RA and psoriatic arthritis (PsA).

The approval for the expanded indication is based on clinical and radiographic data from the 2-year PREMIER study of 799 methotrexate-naïve patients. Results showed that patients taking Humira (subcutaneous injection) in combination with methotrexate exhibited superior efficacy endpoints, including inhibition of joint damage, improvement in signs and symptoms, and clinical remission, compared with patients on methotrexate alone.

The FDA also approved Humira for reducing the signs and symptoms of active arthritis in patients with PsA. The approval for PsA is based on clinical trial data from the ADEPT study (Adalimumab Effectiveness in Psoriatic Arthritis Trial) of 313 adult patients with moderate to severely active PsA who had an inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy. Patients treated with Humira experienced significantly greater improvement in both joint and skin disease symptoms at 24 weeks than placebo-treated patients.

Abbott also announced the simultaneous submission of a supplemental Biologics License Application with the FDA and a Type II Variation to the EMEA seeking approval to market Humira as a treatment for ankylosing spondylitis (AS). The regulatory submissions include results from the ATLAS study, which showed a significant reduction in signs and symptoms, partial remission, and improvement of health-related quality of life in patients with AS compared with placebo-treated patients at 6 months. The ATLAS findings will be reported at the American College of Rheumatology congress in San Diego, California, next month. The regulatory submission for AS is the third autoimmune disease indication filed of five autoimmune diseases Abbott is currently targeting for Humira. 

—A. Techman