Abbott Laboratories, of Abbott Park, Illinois, announced that Humira® (adalimumab) was approved by the European Commission for marketing in Europe as a treatment for severe, active ankylosing spondylitis (AS), a chronic disease of the axial skeleton and large peripheral joints that causes inflammatory back pain and stiffness, and in its severe form can result in complete spinal fusion. Humira is indicated for the treatment of adults with severe, active ankylosing spondylitis who have had inadequate response to conventional therapy.

Humira will be available immediately to patients with AS in several EU countries, including Germany, Spain, Finland, and Denmark. Availability in other EU countries will occur in subsequent months as each country adopts pricing and reimbursement policies. Humira is also approved in the EU for the treatment of severe, active and progressive rheumatoid arthritis and psoriatic arthritis. Abbott's application for Humira for AS in the US is currently under review.

To date, Humira has been approved in 65 countries and is prescribed to more than 150,000 patients worldwide. Clinical trials are currently underway evaluating the potential of Humira in other autoimmune diseases.

—A. Techman