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    ABBOTT PARK, Ill. (PRNewswire) - ABBOTT PARK, Ill., Oct. 1 /PRNewswire-FirstCall/ -- Abbott Laboratories announced today that it has submitted a supplemental Biologics Licensing Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of the use of HUMIRA(R) to improve physical function in patients with moderately to severely active rheumatoid arthritis (RA). This submission comes less than nine months after FDA approval of HUMIRA in December 2002.

    "For RA patients, performing simple tasks such as walking up stairs, buttoning a shirt, or driving a car is difficult and often impossible because of their disease," said Michael Schiff, M.D., director of clinical research, Denver Arthritis Clinic. "In patients treated with HUMIRA in clinical trials, we have seen significant improvement in their ability to perform these activities."

    In September, the European Commission granted marketing authorization to HUMIRA for the treatment of adult rheumatoid arthritis (RA). With European Union marketing authorization, HUMIRA became the first human monoclonal antibody approved in Europe for RA, and the first tumor necrosis factor alpha (TNF-a) antagonist approved with an indication for use with methotrexate or as monotherapy. HUMIRA is indicated for the treatment of moderate to severe active RA in adult patients when the response to disease modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate.

    "Abbott is committed to exploring the full therapeutic potential of HUMIRA in rheumatoid arthritis as well as other autoimmune disease," said Jim Lefkowith, M.D., divisional vice president, Immunosciences Development, Abbott Laboratories. "Our overall goal is to provide patients a treatment option that will improve their everyday living."

    Clinical trials are currently under way evaluating the potential of HUMIRA in juvenile rheumatoid arthritis (JRA), psoriasis, psoriatic arthritis, Crohn's disease and early RA.

    About HUMIRA

    HUMIRA is the first human monoclonal antibody approved by the FDA for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active rheumatoid arthritis (RA) who have had insufficient response to one or more traditional disease modifying antirheumatic drugs (DMARDs). HUMIRA can be used alone or in combination with methotrexate (MTX) or other DMARDs. HUMIRA was created using phage display technology, resulting in an antibody with human-derived heavy and light chain variable regions and human IgG1:K constant regions.

    HUMIRA was discovered through a broad scientific collaboration between Abbott and Cambridge Antibody Technology (CAT). As part of the collaboration, Abbott had the right to select several target antigens for which a joint Abbott/CAT research team would discover human antibody therapeutics. HUMIRA was isolated and optimized by Abbott and CAT as part of this collaboration. Abbott owns exclusive worldwide rights to HUMIRA, including responsibility for clinical development, manufacturing, sales and marketing. Abbott will book all revenues for HUMIRA, and CAT will receive a royalty fee based on HUMIRA sales.

    Important Safety Information

    Cases of tuberculosis (TB), frequently disseminated or extra pulmonary at clinical presentation, have been observed in patients receiving HUMIRA. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these infections occurred in patients on concomitant immunosuppressive therapy that in addition to their underlying disease could predispose them to infections. Other invasive opportunistic fungal infections have also been observed in patients treated with TNF-blocking agents, including HUMIRA.

    TNF-blocking agents, including HUMIRA, have been associated in rare cases with exacerbation of demyelinating disease. The most frequent adverse events seen in the placebo-controlled clinical trials (HUMIRA vs. placebo) were injection site reactions (20 percent vs. 14 percent) upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.

 
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