Posted by Michael Wonder on 01 Aug 2018
Xeljanz (tofacitinib citrate) receives marketing authorisation in the European Union for moderately to severely active ulcerative colitis
1 August 2018 - Pfizer announced today that the European Commission has approved Xeljanz (tofacitinib citrate) 10 mg twice-daily for at least eight weeks, followed by Xeljanz 5 mg twice daily or 10 mg twice daily, for the treatment of adult patients with moderately to severely active ulcerative colitis 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 inhibitor to be approved for this patient population.
The EC approval follows the review of the application for marketing authorisation which included data from three pivotal Phase 3 studies from the Oral Clinical Trials for tofAcitinib in ulceratiVE colitis global clinical development program (OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain), and OCTAVE Open, an ongoing open label long-term extension study.
