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Pfizer Inc. has been cleared by the Food and Drug Administration to market Xeljanz, a medication for rheumatoid arthritis.
The company said Wednesday that Xeljanz (tofacitinib citrate) represents the first new oral disease-modifying antirheumatic drug for rheumatoid arthritis (RA) in over 10 years.
Specifically, Xeljanz is indicated for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. According to Pfizer, the drug is designed to inhibit the JAK pathways, which are signaling pathways inside the cell that play an important role in the inflammation involved in rheumatoid arthritis.
"Xeljanz is an important new option that could potentially change the way rheumatologists treat this serious autoimmune disease," stated 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."
Pfizer said Xeljanz is approved as a second-line medicine for rheumatoid arthritis, meaning that treatment with a biologic isn’t required before taking it.
"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," commented study investigator Stanley Cohen, M.D., 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."
