The European Commission approved Pfizer’s twice-daily, oral Janus kinase (JAK) inhibitor Xeljanz® (tofacitinib citrate), in combination with methotrexate therapy, for treating moderate-to-severe rheumatoid arthritis (RA) in adult patients who don’t respond well or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Xeljanz can also be used as monotherapy when methotrexate treatment isn’t suitable.

Approval of Xeljanz in Europe is based in data from the global Phase III Oral Rheumatoid Arthritis Trials (ORAL) program. “With the approval of tofacitinib, rheumatologists and patients in the EU now have an additional treatment option for the management of rheumatoid arthritis that can be taken with or without methotrexate,” said Ronald van Vollenhoven, M.D., Ph.D., professor of rheumatology and director of the Amsterdam Rheumatology and Immunology Center ARC. “This is an important advancement for the rheumatology community as up to one-third of people with rheumatoid arthritis may not achieve a response with current treatments and a number of patients may not sustain a response.”

Xeljanz has been cleared in more than 45 countries for use as second-line therapy for moderate-to-severe RA, after failure of one or more DMARDs. The latest approval, in China, was announced earlier this month. Xeljanz was first approved in the U.S. in 2012, and in February 2016 FDA cleared a, once-daily, extended-release formulation, Xeljanz XR®.  Global sales of Xeljanz were $927 million in 2016, up from $523 million in 2015, up 77% on 2015.

Xeljanz is in Phase III development for treating ulcerative colitis and psoriatic arthritis. Positive data from the Phase III OPAL Broaden and Beyond studies evaluating Xeljanz as second-line therapy in adults with psoriatic arthritis were reported in November 2016.

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