The European Commission (EC) has approved Pfizer's Xeljanz (tofacitinib citrate) oral tablets to treat moderate-to-severe active rheumatoid arthritis (RA) in adult patients in the European Union (EU).
The 5mg twice-daily (BID) tablets have been approved in combination with methotrexate (MTX) for patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Xeljanz belongs to a new class of therapies called Janus kinase (JAK) inhibitors, and can be given as monotherapy in case of intolerance to MTX, or when treatment with MTX is otherwise inappropriate.
Pfizer Innovative Health Inflammation & Immunology regional president Angela Lukin said: “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.
“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.”
The approval decision was based on results received from the Phase III Oral Rheumatoid Arthritis trials (ORAL) global development programme and real world data.
Xeljanz is now approved for prescription in more than 80 countries worldwide, and Pfizer is now working with the appropriate authorities in EU countries to support reimbursement and availability of the tablets.
RA is a chronic, inflammatory autoimmune disease that causes a range of symptoms such as pain and swelling in the joints, particularly those in the hands, feet and knees.
Tofacitinib is included in several RA treatment recommendations, including those published by the European League Against Rheumatism (EULAR), the American College of Rheumatology (ACR) and Asia Pacific League of Associations for Rheumatology (APLAR).
Image: Xeljanz 5mg bottle. Photo: courtesy of Business Wire.