EMA accepts Pfizer’s MAA for Xeljanz in rheumatoid arthritis

The European Medicines Agency (EMA) has accepted for review Pfizer’s Marketing Authorisation 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).

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 programme in RA. This programme 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 programme 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.

Commenting on the announcement, Michael Corbo, Category Development Lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business, said: “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. 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 US in 2012, it has been prescribed to more than 50,000 patients worldwide.