Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA)for the XELJANZ ® (tofacitinib citrate) rheumatoid arthritis (RA) indication seeking expansion of the label to include inhibition of progression of structural damage. The FDA will review the sNDA and is expected to provide a decision by February 2014, based on the anticipated Prescription Drug User Fee Act (PDUFA) action date for the sNDA.
XELJANZ 5 mg twice daily (BID) was approved by the FDA in November 2012 for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate (MTX), and is the first approved RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors. In the United States, XELJANZ may be used as monotherapy or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs). XELJANZ should not be used in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine.
The sNDA is supported by the results of ORAL Start (A3921069), a 24-month Phase 3 randomized, double-blind, controlled trial in MTX-naïve patients with moderately to severely active RA who were randomized to receive XELJANZ 5 or 10 mg BID or MTX. A pre-planned interim 12-month analysis showed that XELJANZ 5 and 10 mg BID as monotherapy were superior to MTX, with statistically significantly greater inhibition of structural damage, as measured by mean change from baseline in the van der Heijde modified Total Sharp Score (mTSS), and statistically significantly greater improvement in signs and symptoms of RA, as measured by ACR70 response rates. Both primary endpoints assessed XELJANZ versus MTX at six months. No new safety signals emerged in the ORAL Start study, and the safety profile of XELJANZ was consistent with that seen previously in the clinical development program.