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US FDA accepts Pfizer sNDA to expand Xeljanz labeling

The USFDA has accepted Pfizer's supplemental new drug application (sNDA) to expand labeling of rheumatoid arthritis medication Xeljanz (tofacitinib citrate) to include inhibition of structural damage progression.


The data from ORAL Start (A3921069), a 24-month Phase 3 randomized trail conducted in methotrexate (MTX)-naïve patients with moderately to severely active RA is included in the sNDA.

With statistically significantly greater inhibition of structural damage and statistically significantly greater improvement in signs and symptoms of RA, Xeljanz 5 and 10mg BID as monotherapy were superior to MTX.

In November 2012, the FDA cleared Xeljanz 5mg twice daily (BID) for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to MTX.

Used as monotherapy or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs) in the US, Xeljanz became the the first approved RA treatment in a new class of medicines identified as Janus kinase inhibitors.

  UpdateTime:2013-06-24 22:14:36  【Printing】  【Close
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