Pfizer Inc. announced today that the EMA has accepted for review the Marketing Authorization Application (MAA) for XELJANZ® (tofacitinib citrate) 5 mg tablets twice daily for the treatment of patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX). The EMA will now initiate its review of the XELJANZ MAA.
This application provides additional information to the original MAA submission, including data from the Phase 3 ORAL (Oral Rheumatoid Arthritis Phase 3 TriaLs) global development program in RA. This program consisted of six completed clinical trials, in addition to two open-label long-term extension (LTE) studies, one of which is still ongoing. To date, the ORAL development program has accumulated more than 19,400 patient-years of drug exposure having been studied in more than 6,100 patients including follow-up observations of up to eight years in the LTE study.
“We are committed to making XELJANZ available to RA patients in the EU. The up to eight years of data that we have accumulated demonstrate our commitment to understanding the efficacy and safety of XELJANZ in patients living with RA,” said Michael Corbo, Category Development Lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business. “We look forward to working together with the EMA on its review.”
XELJANZ is the only oral Janus kinase (JAK) inhibitor approved in more than 45 countries around the world for the treatment of moderate to severe RA. Since XELJANZ was first approved in the U.S. in 2012, it has been prescribed to more than 50,000 patients worldwide.
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Filed Under: Drug Discovery
