Pfizer announced that the FDA has approved a supplemental New Drug Application (sNDA) to update the current label of Xeljanz (tofacitinib citrate) tablets to include radiographic data from two Phase 3 studies, ORAL Scan and ORAL Start.
Xeljanz is an oral JAK inhibitor currently indicated for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) 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).
The label update includes the radiographic response data from ORAL Scan (Study IV) at 6 months and ORAL Start (Study VI) at 6 and 12 months. These studies evaluated the efficacy of Xeljanz on the progression of structural joint damage as measured by mean change from baseline in van der Heijde modified Total Sharp Score (mTSS) and its components, erosion score, and joint space narrowing (JSN) score.
In ORAL Scan, 74% of patients in the placebo + MTX group experienced no radiographic progression at Month 6 compared to 84% of patients treated with Xeljanz 5mg twice daily + MTX. In ORAL Start, 55% of patients in the MTX group experienced no radiographic progression at Month 6 compared to 73% of patients treated with Xeljanz 5mg twice daily.
For more information call (800) 438-1985 or visit Xeljanz.com.