Abbott's HUMIRA Approved in Europe for Treatment of Ulcerative Colitis
Abbott announced that the European Commission has approved HUMIRA®(adalimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response to conventional therapy. With this approval, HUMIRA becomes the first and only self-injectable biologic therapy for the treatment of moderately to severely active ulcerative colitis in adults. The approval also marks the seventh indication for HUMIRA in the European Union since the product's first approval in 2003.
"This is a difficult-to-treat chronic disease with limited treatment options," said William J. Sandborn, M.D., chief, Division of Gastroenterology at UC San Diego Health System and lead investigator. "A new therapeutic option used for the induction and maintenance of remission, with the convenience of self-administering at home is welcomed among this unique patient population."
The approval was based on two Phase III clinical trials involving more than 800 patients in 21 countries across the globe.
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