Pfizer Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of patients with moderate to severe active rheumatoid arthritis (RA). The CHMP’s opinion will now be sent to the European Commission (EC) for final decision. If approved, XELJANZ in combination with methotrexate (MTX) will be indicated for the treatment of moderate to severe active RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs. XELJANZ can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.
“More than 2.9 million people are currently living with moderate to severe rheumatoid arthritis in Europe. Even with multiple therapeutic options, many of these people may not adequately respond to currently available treatments, including methotrexate,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Global Product Development. “The positive CHMP opinion for tofacitinib is an important milestone as we work to bring this new oral treatment option to people in the European Union living with moderate to severe active rheumatoid arthritis.”
The marketing authorisation application (MAA) included data from the Oral Rheumatoid Arthritis Phase 3 TriaLs (ORAL) global development program in RA. This program consisted of six completed clinical trials, ORAL Start, ORAL Solo, ORAL Standard, ORAL Sync, ORAL Scan, and ORAL Step, in addition to two open-label long-term extension (LTE) studies. At the time of the MAA submission, the ORAL development program had accumulated more than 19,000 patient-years of drug exposure in over 6,100 patients with follow-up observations of up to eight years in one of the LTE studies.
Tofacitinib is part of the Janus kinase (JAK) inhibitor class of medications. This will be a new class of medicines for the treatment of moderate to severe active RA in the EU. About Rheumatoid Arthritis (RA) 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 for 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 17.6 million people worldwide and more than 2.9 million people in Europe. It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.
About XELJANZ (tofacitinib citrate) XELJANZ® (tofacitinib citrate) has been approved for use in over 50 countries. Since tofacitinib was first approved in the U.S. in 2012, it has been prescribed to more than 85,000 patients worldwide. In the European Union (EU), XELJANZ is an investigational medicine and has not been approved for use. Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of XELJANZ through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.
XELJANZ/XELJANZ XR is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. XELJANZ/XELJANZ XR may be used as a single agent or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.
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