EC Grants Marketing Authorization to Xeljanz for Moderate-to-Severe Active RA

Pfizer announced that the European Commission (EC) has approved XELJANZ (tofacitinib citrate) 5 mg twice daily (BID) oral tablets 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. XELJANZ belongs to a new class of therapies called Janus kinase (JAK) inhibitors.

“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, 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.”

The EC approval is based on a submission package that included results from the Phase 3 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.

“With a heritage of more than 60 years of providing rheumatoid arthritis treatment options, Pfizer has been a leader in helping to improve the lives of people with inflammatory conditions,” said Angela Lukin, Regional President, Inflammation & Immunology, Pfizer Innovative Health. “The approval of XELJANZ in Europe demonstrates Pfizer’s ongoing commitment to developing medicines that address unmet needs for people living with chronic conditions like rheumatoid arthritis.”

Pfizer is working with the appropriate authorities in European Union (EU) countries to support reimbursement and availability of XELJANZ with the goal of helping to ensure people who may benefit from XELJANZ have access to it. With the approval in the EU, XELJANZ is now approved for use in more than 80 countries worldwide.