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news.The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for Pfizer's XELJANZ (tofacitinib citrate) 5 mg tablets twice daily for the treatment of patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX).
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The EMA will now initiate its review of the XELJANZ MAA. This application provides additional information to the original MAA submission, including data from the Phase 3 ORAL (Oral Rheumatoid Arthritis Phase 3 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 eight 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 U.S. in 2012, it has been prescribed to more than 50,000 patients worldwide.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease that causes a range of symptoms, including pain and swelling in the joints, particularly those in the hands, feet and knees. Although the exact cause of RA is unknown, it is considered to be an autoimmune disease, because the immune system in people with RA mistakes the body’s healthy tissues for a threat and attacks them. Some people are at increased risk of developing RA, including people with a family history of RA, smokers and women. Three times as many women are affected by RA compared to men. RA affects approximately 23.7 million people worldwide and 1.6 million people in the United States. It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.
About XELJANZ (tofacitinib citrate)
XELJANZ is a prescription medicine called a Janus kinase (JAK) inhibitor.
As the developer of XELJANZ, Pfizer is a leader in JAK innovation. XELJANZ does not require injections or infusions. XELJANZ can be taken with or without methotrexate.
XELJANZ is approved in more than 45 countries around the world for the treatment of moderate to severe RA as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs).
Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of XELJANZ through a robust clinical development program.