EMA accepts for review Pfizer's MAA for Xeljanz for the treatment of moderate to severe rheumatoid arthritis

Application provides additional information to the original MAA submission, including data from the Phase III ORAL global development program in RA.

This application provides additional information to the original MAA submission, including data from the Phase III ORAL (Oral Rheumatoid Arthritis Phase III 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 8 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 US in 2012, it has been prescribed to more than 50,000 patients worldwide.