Pfizer Inc. (PFE) Monday said the U.S. Food and Drug Administration, or FDA, has approved its supplemental New Drug Application, or sNDA, for XELJANZ to include additional Patient-Reported Outcomes data in the label.
"The patient-reported outcomes data show the impact that XELJANZ can have on the daily lives of patients with RA, based on physical, mental and emotional measures," said Steven Romano, SVP and the head of the Medicines Development Group for Pfizer Specialty Care.
XELJANZ 5 mg twice-daily was approved by the FDA in November 2012 for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
The new additional data show improvement in patients receiving XELJANZ based on health-related outcome measures reported by patients, including vitality, role emotional, physical function, bodily pain, social function, mental health, role physical and general health.
In the U.S., XELJANZ may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying antirheumatic drugs.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.