Abbott's HUMIRA Approved in Europe for Expanded Treatment of Crohn's Disease (CD)
Abbott announced that the European Commission (EC) has approved HUMIRA® (adalimumab) for the treatment of moderately active Crohn's disease (CD) in adult patients who have had an inadequate response to conventional therapy. HUMIRA has been approved for severely active CD in adults in the European Union (EU) since 2007.
"The approval of HUMIRA for the treatment of adult patients with moderate CD is an important step to improve treatment in patients suffering from active Crohn's disease," said Paul Rutgeerts, M.D., Ph.D., director, Multidisciplinary Department of Endoscopy and chair of the Inflammatory Bowel Diseases group at the University Hospital Gasthuisberg in Leuven, Belgium. "This label extension provides more patients access to a convenient, self-administered therapeutic option."
The approval is supported by four Phase 2/3 clinical trials which evaluated the use of HUMIRA to induce and maintain clinical remission in adult patients with moderately to severely active CD.
In addition to its approved uses in moderately to severely active CD, HUMIRA is indicated in Europe for the treatment of several other inflammatory diseases including: moderately to severely active rheumatoid arthritis, active and progressive psoriatic arthritis, active polyarticular juvenile idiopathic arthritis, moderate to severe chronic plaque psoriasis, moderately to severely active ulcerative colitis and severe axial spondyloarthritis. The label extension for moderately active CD further supports the use of HUMIRA for the treatment of IBD.
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