CHMP recommends approval of extension to indication for Xeljanz in ulcerative colitis.- Pfizer.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xeljanz (tofacitinib), from Pfizer, to include adults with moderately to severely active ulcerative colitis. The full indication is: Tofacitinib is indicated 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.

Comment: Xeljanz, made by Pfizer Labs, was previously approved in 2012 for rheumatoid arthritis and in 2017 for psoriatic arthritis, and was approved for ulcerative colitis by the FDA in May 2018.