- Ankylosing Spondylitis Is the Third in a Series of Autoimmune Diseases Targeted for HUMIRA Therapy - ABBOTT PARK, Ill., April 28 /PRNewswire-FirstCall/ -- Abbott today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), granted a positive opinion recommending approval of HUMIRA(R) (adalimumab) for the treatment of severe active ankylosing spondylitis. The positive opinion is based on results from the Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS) Phase III clinical trial. In October 2005, Abbott submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) seeking approval to market HUMIRA as a treatment for AS. Ankylosing spondylitis (AS) is a chronic disease of the axial skeleton and large peripheral joints that causes inflammatory back pain and stiffness but is also associated with other inflammatory diseases of the skin and intestines. Unlike many other rheumatic conditions, AS affects young adults, mostly men, and commonly begins before the age of 35. AS is difficult to diagnose in its early stages and often is an overlooked cause of persistent back pain in young adults. In its severe form, AS over time can result in complete spinal fusion, causing extreme physical limitation. It is estimated that nearly three million people in Europe are affected by a spondyloarthritis, such as AS. "The positive opinion is encouraging news for European ankylosing spondylitis patients because it signals that a new treatment option will soon be available to address the symptoms of the disease," said Desiree van der Heijde, M.D., co-lead investigator of ATLAS and Professor of Rheumatology at the Maastricht University, The Netherlands. The European Commission is expected to issue a decision granting the marketing authorization for HUMIRA as a treatment of AS in the European Union within approximately 60 days. Highlights of the ATLAS Study Ankylosing spondylitis patients (n = 315), who had an inadequate response to at least one nonsteroidal anti-inflammatory drug (NSAID) or disease- modifying antirheumatic drug (DMARD), were randomized to receive either placebo or HUMIRA 40 mg subcutaneously every other week for 24 weeks. Results recorded after 12 weeks and 24 weeks of treatment showed that HUMIRA significantly reduced signs and symptoms (the study's primary endpoint), including pain and inflammation, in patients with severe active AS. Findings also indicated HUMIRA reduced disease activity, induced partial remission, improved physical function and improved physical quality of life. ATLAS study data showed that 58 percent of the trial participants receiving HUMIRA therapy achieved and sustained at least a 20 percent reduction in signs and symptoms of pain and inflammation at 12 weeks (ASAS 20, one of the study's primary endpoints). Responses were measured using the ASsessment in AS (ASAS) International Working Group criteria, which evaluate four primary parameters: function, pain, patient's global assessment, and inflammation. At week 24, 42 percent of patients treated with HUMIRA, compared to 16 percent of patients taking placebo, achieved at least a 50 percent reduction of disease activity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), a patient-assessed composite index of disease activity measuring pain, stiffness and fatigue. Also at week 24, approximately one out of five patients achieved partial remission (defined as a value 1/100 and 1/10 patients. Patients must be monitored closely for infections, including tuberculosis (TB), before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. HUMIRA should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections. TNF antagonists, including HUMIRA, have been associated in rare cases with exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. Prescribers should exercise caution in considering the use of HUMIRA in patients with pre-existing or recent-onset central nervous system demyelinating disorders. Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully. In clinical studies with another TNF antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events including worsening CHF and new onset CHF have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA. About HUMIRA Rheumatoid Arthritis: HUMIRA, in combination with methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying antirheumatic drugs including methotrexate has been inadequate as well as for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment of methotrexate is inappropriate. HUMIRA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Psoriatic Arthritis: HUMIRA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. To date, HUMIRA has been approved in 65 countries and prescribed to more than 150,000 patients worldwide. Clinical trials are currently underway evaluating the potential of HUMIRA in other autoimmune diseases. About Abbott Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 60,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/ . DATASOURCE: Abbott CONTACT: International Media, Kellie Harris, +1-847-937-9789, or U.S. Media, Elizabeth Shea, +1-847-935-2211, or Financial Community, John Thomas, +1-847-938-2655, all of Abbott Web site: http://www.abbott.com/ Company News On-Call: http://www.prnewswire.com/comp/110328.html

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