Humira Approved (updated Jan 01, 2007)

ABBOTT'S HUMIRA RECEIVES APPROVAL FROM FDA AND THE EUROPEAN COMMISSION

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.

This is the third in a series of autoimmune diseases targeted for HUMIRA therapy. HUMIRA also is approved in the European Union for the treatment of severe, active and progressive rheumatoid arthritis and psoriatic arthritis.

"This approval of HUMIRA in the European Union is important in the treatment of ankylosing spondylitis, a debilitating disease that strikes young, mostly male patients in their thirties and forties," said Désirée van der Heijde, M.D., co-lead investigator of the ATLAS Phase III clinical trial and Professor of Rheumatology at the Maastricht University, The Netherlands. "Treatments like HUMIRA are changing how we can treat AS. The data in the clinical trial showed that treatment with HUMIRA significantly reduced the pain and inflammation caused by AS, and in some patients, led to partial remission."

In its severe form, AS 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.

In June, 2006, it was announced that Abbott had also received approval from the European Commission to market HUMIRA(R) (adalimumab) as a treatment for severe, active ankylosing spondylitis (AS) in Europe. It is estimated that nearly three million people in Europe are affected by a spinal arthritic disease such as AS.

This approval follows a positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). Abbott's application for HUMIRA for AS in the United States is currently under review. It is estimated that nearly three million people in Europe are affected by a spinal arthritic disease such as AS. This is the third in a series of autoimmune diseases targeted for HUMIRA therapy.