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Xeljanz receives European marketing approval for ulcerative colitis
The European Commission granted marketing authorization to Xeljanz for the treatment of moderately to severely active ulcerative colitis.
Xeljanz (tofacitinib, Pfizer) is the first oral Janus kinase inhibitor to receive approval for patients who either lost response or were intolerant to conventional therapy or a biologic agent, according to a press release.
“Ulcerative colitis is a chronic disease that can develop at any age, be difficult to manage and affect multiple aspects of daily life,” Angela Lukin, regional president for inflammation and immunology at Pfizer said in the release. “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.”
The group approved a dose of 10 mg twice daily for 8 weeks followed by 5 mg or 10 mg twice daily. The approval was supported by data from three phase 3 studies from the OCTAVE trial, as well as the open label, long-term extension study, OCTAVE Open, according to the press release.
The FDA approved Xeljanz for the treatment of UC in the United States in May 2018, and in Europe, it currently has approval for the treatment of rheumatoid arthritis and psoriatic arthritis.
Disclosures: Lukin is employed by Pfizer.