Leaders with the European Medicines Agency (EMA) recently announced that the organization has accepted the marketing authorization application for Xeljanz, a new treatment for moderate to severe rheumatoid arthritis (RA), developed by Pfizer Inc.
The new treatment needs to be administered twice each day through five-milligram tablets. The goal is to relieve the pain and symptoms of patients who have moderate to severe rheumatoid arthritis, particularly if they have not responded to, or are intolerant of, methotrexate.
The EMA's next step will be to review the application for the new drug.
The application gives additional information, such as data taken from the phase-three Oral Rheumatoid Arthritis Trials (ORAL) worldwide development program to treat rheumatoid arthritis. The program includes six completed clinical trials as well as two open label long-term extension (LTE) studies. One of these two studies is still being conducted.
As of today, the program has gathered information from more than 19,400 patient-years of exposure to the drug, studied in over 6,100 patients. There have also been follow-up observations, up to eight years after the LTE study.
“We are committed to making Xeljanz available to RA patients in the EU,” Michael Corbo, category development lead for inflammation and immunology, Pfizer Global Innovative Pharmaceuticals Business, said. “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.”