First biologic for AS has received FDA approval

The FDA has approved the use of Enbrel (etanercept) (25 mg twice weekly), the first biologic to reduce the signs and symptoms in patients with active ankylosing spondylitis.

Enbrel is produced by Amgen from Thousand Oaks, CA, US and Wyeth Pharmaceuticals, a division of Wyeth from Collegeville, PA, US, and the FDA's decision is the fourth indication for the product.

'The approval of Enbrel for the treatment of AS offers 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,' said Kevin Young, vp of Amgen's Inflammation Business Unit.

Ankylosing spondylitis

Ankylosing spondylitis, which affects approximately 350,000 people in the United States, 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, chest, and neck. The spine can fuse, causing loss of motion and a permanent stooped-over posture. 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. It tends to affect more men than women.

About Enbrel

Enbrel is the only fully human anti-TNF receptor approved to reduce the signs and symptoms and inhibit the structural damage in patients with moderately to severely active RA, and to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis. Enbrel can be used in combination or alone. It is also approved to reduce the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients who have had an inadequate response to disease-modifying medicines.