TUESDAY, Feb. 27 (HealthDay News) -- The U.S. Food and Drug Administration has approved Humira (adalimumab) for use in the treatment of adults with moderate to severe Crohn's disease. The drug, which is made by Abbott Laboratories, was previously approved for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. It is labeled with a boxed warning in regards to the increased risk of potentially life-threatening infections, including tuberculosis.
The approval was based on placebo-controlled clinical trials including 1,478 patients. The monoclonal antibody, which inhibits tumor necrosis factor-alpha, is administered subcutaneously and maintenance therapy involves injections every other week. The most common side effects are upper respiratory infections, sinusitis and nausea, in addition to other serious side effects, such as lymphoma.
"Humira has been shown to reduce signs and symptoms, and to induce and maintain clinical remission of Crohn's disease in patients who have had an inadequate response to conventional therapy, and in those patients who did not benefit from treatment, or who were intolerant to previous treatment with Remicade (infliximab) therapy," said Douglas Throckmorton, M.D., deputy director of FDA's Center for Drug Evaluation and Research, in a statement.
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