The Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the European Agency for the Evaluation of Medicinal Products (EMEA), has voted to recommend approval for Wyeth Pharmaceuticals' Enbrel (etanercept) (25 mg twice weekly) for the treatment of adults with severe active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.
This favorable opinion will be forwarded to the European Commission for endorsement before Enbrel receives final Marketing Authorization. If Enbrel is approved for this indication, ankylosing spondylitis will be the fifth indication for Enbrel in the European Community (EC).
Currently it is approved in the EC for rheumatoid arthritis in adults with inadequate response to disease-modifying antirheumatic drugs, including methotrexate (MTX) (unless contraindicated), for rheumatoid arthritis in adults not previously treated with MTX, for adults with psoriatic arthritis, and for children with juvenile chronic arthritis.
"The potential for approval of Enbrel for the treatment of AS is truly exciting, offering many patients significant relief of symptoms such as back pain, morning stiffness, and fatigue as rapidly as two weeks after initiation of therapy. Also, for the first time, we see improvement in spinal mobility, which is a debilitating symptom of the disease," says Robert Power, President, International, Wyeth Pharmaceuticals.
Ankylosing spondylitis is a painful and potentially progressive inflammatory disease affecting joints and ligaments that normally allow a person's back to move and flex. The disease most often occurs in the lower back but can affect the upper spine and neck. The spine can fuse, causing deformity and loss of motion. Ankylosing spondylitis may also involve other joints, such as the hips, shoulders, knees, and ankles. Unlike some other forms of arthritis, AS frequently strikes between the ages of 16 and 30, and tends to affect more men than women. It is estimated that there are more than 600,000 patients with AS in Europe and 350,000 in the United States.