Amgen and Wyeth Pharmaceuticals, a division of Wyeth announced that Enbrel (etanercept) (25 mg twice weekly) is the first biologic to be approved by the U.S. Food and Drug Administration (FDA) to reduce the signs and symptoms in patients with active ankylosing spondylitis (AS). Ankylosing spondylitis marks the fourth indication for Enbrel. The FDA's decision follows an expedited review.
"The 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," said Kevin Young, vice president of Amgen's Inflammation Business Unit.
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.
"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.
"We are pleased to now be able to offer Enbrel to physicians and patients battling ankylosing spondylitis," said Dr. Victoria Kusiak, vice president of global medical affairs and North American medical director of Wyeth Pharmaceuticals. "Enbrel has a history of proven efficacy and tolerability which will be important to physicians introducing the therapy to a new group of patients."