European Commission approves XELJANZ for rheumatoid arthritis

XELJANZ (tofacitinib citrate) has been approved by the European Commission in mono or combination therapy for rheumatoid arthritis.
XELJANZ 5 mg oral tablets were approved for twice-daily use in combination with methotrexate (MTX) or as monotherapy if the patient has an intolerance to MTX or if MTX treatment is inappropriate.
“With the approval of tofacitinib, rheumatologists and patients in the E.U. now have an additional treatment option for the management of rheumatoid arthritis that can be taken with or without methotrexate,” Amsterdam Rheumatology and Immunology Center ARC Director Ronald van Vollenhoven said. “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.”
The EC approval was based in part on the results of the Phase III Oral Rheumatoid Arthritis Trials that tested the efficacy and safety of XELJANZ with and without MTX therapy. More than eight years of safety data from long-term studies of XELJANZ were included in the submission package.
XELJANZ is a new class of drugs called JAK inhibitors. XELJANZ works inside the cell on the JAK pathway to help reduce inflammation in moderate to severe rheumatoid arthritis.