Pfizer Receives FDA Approval For XELJANZ - Quick Facts

(RTTNews) - 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.