FDAnews
www.fdanews.com/articles/61310-abbott-s-humira-receives-fda-approval

ABBOTT'S HUMIRA RECEIVES FDA APPROVAL

July 31, 2006

Abbott announced that the FDA has approved Humira (adalimumab) for reducing signs and symptoms in patients with active ankylosing spondylitis, an autoimmune disease that affects the spine and large peripheral joints and causes inflammatory back pain and stiffness. In its severe form, it can result in complete spinal fusion, causing extreme physical limitation.

Humira also is approved to treat rheumatoid arthritis and psoriatic arthritis, and clinical trials are currently under way evaluating the potential of the drug in other autoimmune diseases.

The drug is currently available in a pre-filled syringe. Beginning in August, patients will be able to take advantage of the Humira Pen, a new delivery device for the self-administration of the drug.