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FDA Approves Extended-Release Tofacitinib (Xeljanz XR) for Rheumatoid Arthritis

First once-daily oral JAK inhibitor treatment for RA indication

The FDA has given the green light to extended-release tofacitinib citrate tablets (Xeljanz XR, Pfizer) for the once-daily treatment of moderate-to-severe rheumatoid arthritis (RA) in patients who have had an inadequate response to or are intolerant of methotrexate. Extended-release tofacitinib is the first and only once-daily oral RA treatment in the class of Janus kinase (JAK) inhibitors.

Both the standard and extended-release formulations of tofacitinib (Xeljanz and Xeljanz XR) do not require injections or infusions. Either drug can be taken with or without methotrexate.

Tofacitinib is approved in more than 45 countries for the treatment of moderate-to-severe RA as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs). The efficacy and safety profiles of tofacitinib have been studied in approximately 6,200 patients with moderate-to-severe RA, representing more than 19,400 patient-years of drug exposure in the treatment’s global clinical development program.

Tofacitinib is the only JAK inhibitor included in the 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis.

The use of either standard or extended-release tofacitinib in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended. It is not known whether the two formulations of tofacitinib are safe and effective in patients with hepatitis B or C, or in pediatric patients. Neither formulation should be used in patients with severe liver problems.

RA is a chronic, inflammatory autoimmune disease that causes a range of symptoms, including pain and swelling in the joints, particularly those in the hands, feet, and knees. Although the exact cause of RA is unknown, it is considered to be an autoimmune disease. Some people are at increased risk of developing RA, including those with a family history of RA, smokers, and women. Three times as many women have RA compared with men. RA affects approximately 1.6 million people in the U.S. It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.

Source: Pfizer; February 24, 2016.

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