The Food and Drug Administration has approved a once-daily, extended-release tablet formulation of tofacitinib 11 mg, the drug’s manufacturer, Pfizer, announced.
The Janus kinase inhibitor, to be marketed as Xeljanz XR, is indicated for the treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate, but it can be used with methotrexate.
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“The availability of Xeljanz XR provides physicians with a new treatment option for people with RA who may prefer an oral once-daily treatment,” Dr. Roy Fleischmann, clinical professor in the department of internal medicine at the University of Texas Southwestern Medical Center, Dallas, said in Pfizer’s announcement.
The original 5-mg tofacitinib tablet, approved in 2012, is taken twice daily.
According to Pfizer, the global clinical development program for tofacitinib has evaluated its safety and efficacy in approximately 6,200 patients with moderate to severe RA, amounting to more than 19,400 patient-years of drug exposure.
The new labeling can be found here.