Pfizer receives EU nod for Ulcerative Colitis drug XELJANZ

Pfizer has announced that the European Commission (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 with moderately to severely active ulcerative colitis (UC) 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 (EMA) Committee for Human Medicinal Products (CHMP) has, as part of its assessment, determined XELJANZ to be of significant clinical benefit for patients with UC in comparison with existing therapies.

"Ulcerative colitis is a chronic disease that can develop at any age, be difficult to manage and affect multiple aspects of daily life," said Angela Lukin, regional president, Inflammation and Immunology, Pfizer. "The EC approval of XELJANZ provides an additional treatment option that can help improve the care of adults in Europe living with this debilitating inflammatory bowel disease."

XELJANZ is now approved for three indications in the EU. In 2017, XELJANZ, in combination with methotrexate (MTX), was first approved by the EC for the treatment of moderate to severe active rheumatoid arthritis (RA). In June 2018, XELJANZ, in combination with MTX, was approved by the EC for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.

"Until now, people living with moderately to severely active ulcerative colitis have not had an oral treatment available that can both induce and maintain steroid-free remission," said Silvio Danese, head of IBD Center, Department of Gastroenterology Humanitas Research Hospital, Milan, Italy, President of the European Crohn’s and Colitis Organisation (ECCO) Governing Board. "This approval of XELJANZ, the first JAK inhibitor to be approved for this condition, offers the ulcerative colitis community an additional treatment option."

The EC approval follows the review of the application for marketing authorization 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.3,4

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