EMA to review Pfizer’s Xeljanz for patients with rheumatoid arthritis
pharmafile | March 24, 2016 | News story | Research and Development, Sales and Marketing | EMA, Pfizer, Xeljanz, approval, authorisation, marketing, review, rheumatoid arthritis
Pfizer (NYSE: PFE) has announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for Xeljanz (tofacitinib citrate)
Marketing approval is being sought for Xeljanz for the treatment of patients with moderate to severe rheumatoid arthritis who have had an inadequate intolerance to methotrexate. Xeljanz is the only JAK inhibitor approved in more than 45 countries for the treatment of this disease. Since it was granted US approval in 2012, it has been prescribed to more than 50,000 patients worldwide.
The EMA rejected Xeljanz several years ago but this new application provides additional data from the Phase III clinical trials. The ORAL program consisted of six completed clinical trials, as well as two open-label long-term extension (LTE) studies. To date, the 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 studies.
Michael Corbo, category development lead in inflammation and immunology at Pfizer, comments: “We are committed to making Xeljanz available to rheumatoid arthritis 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 rheumatoid arthritis. We look forward to working together with the EMA on its review.”
Sean Murray
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