Abbott's Humira Approved in the European Union for Treatment of Moderate-to-Severe Plaque Psoriasis

In Clinical Trials, Patients Taking HUMIRA Saw Significant and Sustained Skin Clearance

ABBOTT PARK, Ill., December 20, 2007 /PRNewswire-FirstCall/ -- Abbott has received marketing authorization from the European Commission for the use of HUMIRA(R) (adalimumab) as a treatment for moderate-to-severe plaque psoriasis. HUMIRA is the first fully human, self-injectable biologic for the treatment of psoriasis. In one clinical trial, more than 80 percent of patients taking HUMIRA achieved skin clearance of 75 percent or better and in another, almost three quarters of patients achieved 75 percent clearance. In both trials, nearly half of the patients taking HUMIRA achieved 90 percent clearance as early as 16 weeks into treatment. Psoriasis is the fifth approved indication for HUMIRA in the European Union. A regulatory application for HUMIRA to treat psoriasis is also under review with the U.S. Food and Drug Administration.

"Psoriasis is not only a skin disease -- it is a systemic, autoimmune disorder that, in its more severe forms, may require systemic treatment," said Professor Jean-Hilaire Saurat, M.D., chairman, department of dermatology, University of Geneva, Switzerland. "HUMIRA is the first and only biologic that has been compared to methotrexate, and this approval brings an important new option for dermatologists to treat this disease."

Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself. The most obvious physical symptom of the condition is raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. Psoriasis is more than painful skin lesions; data also suggest an association with other health conditions, including psoriatic arthritis. Patients may also suffer from poor self-image and social isolation.

"Patients taking HUMIRA for psoriasis experienced rapid, significant skin clearance and maintained improvement for up to a year," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "This fifth indication for HUMIRA demonstrates its versatility in effectively treating multiple autoimmune disorders from rheumatoid arthritis to Crohn's disease and now psoriasis."