The European Commission (EC) has granted marketing authorisation Pfizer’s Xeljanz for moderately to severely active ulcerative colitis.
Xeljanz is the first and only oral therapy and Janus kinase inhibitor to be approved for this patient population.
“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 in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs), and as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.
In June 2018, Xeljanz, in combination with MTX, was approved by the EC for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.