EU approves Simponi for Ulcerative Colitis in adults
The European Commission has approved Simponi (golimumab), from Janssen Biotech/Merck Inc, for the treatment of moderately to severely active Ulcerative Colitis (UC) in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Approval is based on data that showed induction treatment with Simponi induced clinical response, clinical remission, mucosal healing and improved quality of life as measured by the inflammatory bowel disease questionnaire (IBDQ) in patients with moderately to severely active UC.
Further, per the European Commission�approved Summary of Product Characteristics, maintenance therapy with Simponi maintained clinical response through week 54. In addition, in patients who had initially responded to induction therapy with Simponi, more Simponi-treated patients demonstrated sustained clinical remission and mucosal healing at weeks 30 and 54 compared with patients in the placebo group.
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