Regulatory applications for XELJANZ for the treatment of moderate-to-severe active RA remain under review in more than 30 additional countries. In Europe, Pfizer is seeking a re-examination of the Committee for Medicinal Products for Human Use (CHMP) negative opinion that was announced in April, and the company is currently working with the CHMP on the next steps in the process.
XELJANZ is the first approved RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors. The recent marketing authorizations for XELJANZ were based on data from the comprehensive, global, multi-study clinical development program for XELJANZ, which included approximately 5,000 patients in more than 40 countries, resulting in 7,000 patient-years of experience at the time of regulatory submission.
Important Safety Findings for XELJANZ
Notable safety findings observed in the XELJANZ RA program include serious and other important infections, including tuberculosis and herpes zoster; malignancies, including lymphoma; gastrointestinal perforations; decreased neutrophil and lymphocyte counts; and lipid elevations. The most common serious adverse events were serious infections. The most commonly reported adverse events were upper respiratory tract infections, headache, nasopharyngitis and diarrhea.About Rheumatoid Arthritis Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. RA can be painful and disabling, 1 causing swelling, stiffness and loss of function in the joints. 1 RA affects 23.7 million people worldwide, 2 and although multiple treatments are available, up to one-third of patients do not adequately respond, and about half stop responding to any particular DMARD within five years. 3,4,5,6,7,8 As a result, there remains a need for additional options. About XELJANZ XELJANZ is a novel, oral Janus kinase (JAK) inhibitor for the treatment of RA. Unlike recent therapies for RA, which are directed at extracellular targets such as pro-inflammatory cytokines, XELJANZ takes a novel approach targeting the intracellular pathways that operate as hubs in the inflammatory cytokine network.