The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application for Pfizer’s Xeljanz (5 mg tablets twice daily) to treat adults with moderate to severely active rheumatoid arthritis in which methotrexate did not work well. The EMA will now begin its assessment of the Xeljanz MAA.
This application provides supplementary evidence to the original MAA submission, incorporating results from the Phase 3 ORAL global clinical development program in patients with rheumatoid arthritis.
The clinical development program included of six completedtrials, as well as two open-label extension (LTE) trials. One of these clinical trials is still ongoing. The ORAL clinical development program has accumulated more than 19,400 patient-years of drug exposure, having been investigated in more than 6,100 patients including follow-up observations of up to eight years in the LTE clinical trial.
“We are committed to making Xeljanz available to rheumatoid arthritis patients in the European Union. The up to eight years of data that we have accumulated demonstrates our commitment to understanding the efficacy and safety of Xeljanz in patients living with rheumatoid arthritis,” Michael Corbo, category development lead, Inflammation & Immunology at Pfizer Global Innovative Pharmaceuticals, said in a press release. “We look forward to working together with the EMA on its review.”
Xeljanz has been approved in more than 45 countries for the treatment of patients with a diagnosis of moderate to severe rheumatoid arthritis as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs).
Rheumatoid arthritis is a chronic systemic inflammatory disease of unknown cause that causes disability, premature death, and lowers the quality of life of patients in the industrialized and developing world. Rheumatoid arthritis is a systemic inflammatory disease that manifests itself in multiple joints in the body.
This inflammation usually affects the lining of the joints (synovial membrane), but can also affect other organs. This inflamed joint lining leads to erosions of the cartilage and bone and sometimes causes joint deformity. Pain, swelling, and redness are common joint symptoms.
Xeljanz is now included in the 2015 American College of Rheumatology (ACR) guideline. ACR is a professional membership organization dedicated to improving the care of patients with rheumatic disease, which includes patients with rheumatoid arthritis.