FDA Approves Enbrel® For Treatment of Ankylosing Spondylitis

The U.S. Food and Drug Administration (FDA) has approved Enbrel® (etanercept) for the treatment of ankylosing spondylitis.

This potentially progressive inflammatory disease affects about 350,000 people in the United States, causing pain and affecting joints and ligaments that normally allow a person's back to move and flex. The disease frequently strikes between the ages of 16 and 30, affecting more men than women.

Enbrel, already approved for the treatment of adult and juvenile rheumatoid arthritis and psoriatic arthritis, becomes the first biologic approved to treat ankylosing spondylitis and its symptoms of back pain, morning stiffness and fatigue.

Studies have shown that Enbrel offers significant relief of these symptoms in as quickly as two weeks. The drug has also been shown to improve spinal mobility.

"Ankylosing spondylitis is widely underdiagnosed and in its most severe forms, can be devastating to a person's ability to function at home or work," said Jane Bruckel, RN, executive director of the Spondylitis Association of America.

The key study leading to Enbrel's approval found that 60 percent of patients treated achieved a 20 percent improvement after 12 weeks in a standard measure that includes back pain, morning stiffness, inflammation and physical function, compared with 27 percent of patients receiving a placebo.

Other sources: Amgen and Wyeth Pharmaceuticals