This release has been updated with multimedia.
XELJANZ® Bottle ImagePfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved XELJANZ ® (tofacitinib citrate) 5 mg twice daily for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate. XELJANZ may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs). XELJANZ should not be used in combination with biologic DMARDs or with potent immunosuppressives, such as azathioprine and cyclosporine. XELJANZ (ZEL’ JANS’) is the first approved RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors and the first new oral DMARD for RA in more than 10 years. XELJANZ is approved as a second-line medicine for RA, which means treatment with a biologic is not required before taking XELJANZ. “XELJANZ is an important new option that could potentially change the way rheumatologists treat this serious autoimmune disease,” said Ian Read, chairman and chief executive officer of Pfizer. “With its novel mechanism of action, the discovery and development of XELJANZ by Pfizer scientists reflects our commitment to R&D innovation and our dedication to bringing important and meaningful medicines to patients.” XELJANZ is specifically designed to inhibit the JAK pathways, which are signaling pathways inside the cell that play an important role in the inflammation involved in RA. With one of the largest clinical databases of any RA drug ever submitted to the FDA for review, the comprehensive, multi-study, global clinical development program evaluated approximately 5,000 patients who represent a broad cross-section of the RA patient population. “RA is a serious and disabling disease that affects people in their everyday lives, and many patients do not adequately respond or are intolerant to currently available therapies,” said study investigator Stanley Cohen, MD, clinical professor of rheumatology at the University of Texas Southwestern Medical School; co-director, Division of Rheumatology, Presbyterian Hospital Dallas; and co-medical director, Metroplex Clinical Research Center. “In clinical trials, XELJANZ significantly reduced the signs and symptoms of RA and improved physical function. As a physician, I am pleased that we have another choice for patients living with inadequately controlled, moderately to severely active RA.”