Pfizer Inc. (PFE) announced Wednesday that XELJANZ (tofacitinib citrate) has received marketing authorization in the European Union for moderately to severely active Ulcerative Colitis or UC.
The company noted that the European Commission or EC has approved XELJANZ 10 mg twice-daily (BID) for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
XELJANZ is the first and only oral therapy and Janus kinase (JAK) inhibitor to be approved for this patient population.
In approving XELJANZ for UC, the European Medicines Agency's Committee for Human Medicinal Products or CHMP has, as part of its assessment, determined XELJANZ to be of significant clinical benefit for patients with UC in comparison with existing therapies.
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