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news.The European Commission has granted approval for Centocor and Schering-Plough's Remicade for the treatment of moderately to severely active ulcerative colitis.
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This new approval also marks the eighth indication Remicade has received in Europe for the treatment of immune-mediated inflammatory disorders.
The approval is specifically for patients who have had an inadequate response to conventional therapy, including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Remicade becomes the first biologic therapy approved to treat moderately to severely active ulcerative colitis (UC) in the European Union, addressing an unmet medical need for patients who previously had limited treatment options.
“Our research demonstrated that UC patients treated with Remicade achieved mucosal healing and disease remission while they had failed conventional therapies,” said Dr Paul Rutgeerts of University Hospital Gasthuisberg in Belgium and lead investigator in a key trial of the drug in UC.
This approval follows a positive opinion adopted on January 26, 2006 by the Committee for Medicinal Products for Human Use.
The drug now has marketing authorization with unified labeling in all European member states, including the current 25 member states, as well as Iceland and Norway.