FDA Approves Additional Labeling for Xeljanz

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

Data to be included are results from three Phase 3 studies (ORAL Solo, Scan and Step [Studies I, IV, V]), as assessed by the Medical Outcomes Study Short-Form Health Survey (SF-36). 

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At 3 months, patients receiving Xeljanz 5mg twice daily or 10mg twice daily had greater improvement from baseline vs. placebo in all 8 domains of the SF-36, as well as the physical component summary (PCS) and mental component summary (MCS) scores.

The 8 domains of the SF-36 include vitality, role emotional, physical function, bodily pain, social function, mental health, role physical, and general health. Data included at the time of FDA approval showed patients treated with Xeljanz improved physical function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI).

Xeljanz is a janus kinase (JAK) inhibitor indicated for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate (MTX); as monotherapy or in combination with MTX or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs).

For more information call (855) 493-5526 or visit Xeljanz.com.