Pfizer’s sNDA for Xeljanz Indication Expansion Accepted for Review

Pfizer announced that the 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. Xeljanz is the first approved RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors.

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 5mg or 10mg twice daily or MTX. A pre-planned interim 12-month analysis showed that Xeljanz 5mg and 10mg twice daily 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 vs. MTX at six months.

Xeljanz 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). 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.

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