FDA approves supplemental application for expanded Xeljanz labeling

The FDA has approved a supplemental new drug application to expand labeling of tofacitinib citrate to include additional reported outcomes from patients with rheumatoid arthritis, Pfizer has announced.

“These additional data show improvement in patients receiving Xeljanz [tofacitinib citrate] 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, which are the eight domains of the Medical Outcomes Study Short-Form Health Survey (SF-36),” according to a press release.

The FDA action expands US labeling to include results from three phase 3 studies in a Xeljanz clinical development program using SF-36 for assessment. The results at 3months showed that patients with rheumatoid arthritis (RA) receiving 5 mg or 10 mg Xeljanz twice daily displayed greater improvement from baseline compared with patients treated with placebo in all SF-36 domains, and higher physical and mental component summary scores, the release said.

The FDA approved 5 mg Xeljanz twice daily in November 2012 for treating adults with moderately to severely active RA who had inadequate response or intolerance to methotrexate (MTX). The drug, the first Janus kinase inhibitor approved for RA treatment, may be used as monotherapy or combined with MTX or other nonbiologic disease-modifying antirheumatic drugs, according to the release.

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