Enbrel cleared for new use in EU

The European Commission has approved the use of Wyeth and Amgen's Enbrel (etanercept) for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to standard therapy. The product recently became the first biologic approved by the US Food and Drug Administration for this indication (Marketletter August 4, 2003).

The decision by the EC follows a recommendation by the European Union's Committee for Proprietary Medicinal Products (Marketletter October 6, 2003). AS is the fifth indication for Enbrel in the EU; the product is already registered for rheumatoid arthritis in adults with inadequate response to methotrexate, for RA in adults not previously treated with MTX, for adults with psoriatic arthritis and for children with juvenile chronic arthritis.

Clinical evidence