European Medicines Agency will review Pfizer’s Marketing Authorization Application for XELJANZ
XELJANZ is a 5 mg tablet designed to be taken twice a day in order to treat patients suffering from moderate to severe rheumatoid arthritis (RA) who have previously had a negative response or intolerance to methotrexate (MTX). By accepting the MAA, the EMA begins its review process.
The new application includes additional information not included in the original MAA submission. The new information consists of data from the Oral Rheumatoid Arthritis Phase 3 Trials (ORAL), a worldwide RA developmental program. The program is comprised of six clinical trials that have all been completed as well as two open-label long-term extension (LTE) studies. Currently, the ORAL program has accrued more than 19,400 patient-years of exposure to the drug, which was derived from research stemming from more than 6,100 patients. This includes follow-up observations in the eight-year LTE study.
XELJANZ is currently the only oral Janus kinase (JAK) inhibitor that has been approved in more than 45 countries globally to treat moderate to severe RA. XELJANZ has been prescribed to more than 50,000 patients around the world.