New outcomes data to be included on Xeljanz labels

November 19, 2013

FDA has approved the supplemental New Drug Application for tofacitinib citrate (Xeljanz, Pfizer) to include additional patient-reported outcomes data on the label.

FDA has approved the supplemental New Drug Application for tofacitinib citrate (Xeljanz, Pfizer) to include additional patient-reported outcomes data on the label.

"The patient-reported outcomes data show the impact that Xeljanz can have on the daily lives of patients with rheumatoid arthritis, based on physical, mental and emotional measures," said Steven Romano, senior vice president and the head of the medicines development group for Pfizer Specialty Care.

Last year, FDA approved tofacitinib 5 mg twice-daily for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The janus kinase inhibitor can be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying anti-rheumatic drugs.

Pfizer said the new data from three phase 3 studies show improvement in patients receiving tofacitinib 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.