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Humira (adalimumab) Receives FDA Approval for Moderate to Severe Chronic Plaque Psoriasis ABBOTT PARK, IL -- January 21, 2008 -- Abbott announced today it has received U.S. Food and Drug Administration (FDA) approval to market HUMIRA® (adalimumab) as a treatment for adult patients with moderate to severe chronic plaque psoriasis, an autoimmune disease characterized by skin lesions that are sometimes painful and itchy. HUMIRA has been approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. The approval is based on two pivotal trials, REVEAL and CHAMPION, showing that nearly 3 in 4 patients achieved 75 percent clearance or better at week 16 of treatment versus placebo. HUMIRA has 10 years of clinical trial experience beginning with rheumatoid arthritis patients. It was approved for moderate to severe rheumatoid arthritis in 2002, psoriatic arthritis in 2005, ankylosing spondylitis in 2006, and moderate to severe Crohn's disease in 2007. "The approval of HUMIRA for psoriasis is welcome news for people living with this challenging, lifelong disease," said Pam Field, acting president and CEO, National Psoriasis Foundation. "We are pleased to let people with plaque psoriasis know they now have a new treatment option available to them." Psoriasis affects an estimated 125 million people worldwide, with approximately 25 percent of patients experiencing moderate to severe disease. Psoriasis is a serious, sometimes painful autoimmune disease resulting in inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. In addition to visible symptoms, people with psoriasis may suffer from poor self-image and social isolation, and even feelings of depression, such as sadness and despair. Recent research also suggests psoriasis may be associated with other serious health risks. Up to 30 percent of psoriasis patients develop psoriatic arthritis, which combines skin symptoms with arthritis symptoms, including joint pain and inflammation. "The approval of HUMIRA is excellent news for patients suffering from psoriasis, which can have a profound physical and emotional impact on a person's life," said Alan Menter, M.D., chairman, division of dermatology, Baylor University Medical Center, Dallas. "HUMIRA offers dermatologists an important new therapeutic option that has been shown to help alleviate a range of psoriasis signs and symptoms, including redness, scaling and itching, in many psoriasis patients." SOURCE: Abbott Laboratories E-mail this page to a friend or colleague! To print, use this version