EU approves Xeljanz (tofacitinib citrate) for rheumatoid arthritis- Pfizer

The European Commission (EC) has approved Xeljanz (tofacitinib citrate) 5 mg twice daily (BID) oral tablets, from Pfizer, in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Xeljanz can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.

The EC approval is based on a submission package that included results from the Phase III Oral Rheumatoid Arthritis triaLs (ORAL) global development program and real world data. Results from this clinical trial program conducted in a diverse RA patient population demonstrated the efficacy and safety profile of Xeljanz both with and without MTX for the treatment of moderate to severe RA. The Xeljanz development program includes more than eight years of safety data from the long-term extension studies representing over 21,100 patient-years of drug exposure to date.