Pfizer China has received approval from the Chinese Food and Drug Administration (CFDA) to market its oral Janus kinase (JAK) inhibitor, Xeljanz (tofacitinib citrate), in China for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX). It may be used in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs).
Xeljanz is the first JAK inhibitor approved for RA patients. JAK inhibitors act on the JAK pathway by working inside the cell to disrupt a signaling pathway believed to play a role in the inflammation associated with moderately to severely active RA.
“The introduction of the first oral JAK inhibitor for RA in China, Xeljanz, builds upon Pfizer’s legacy as an innovator in inflammation and immunology and provides a new option for physicians and adult patients with moderately to severely active RA who may prefer an oral treatment for this chronic condition,” said Mr. Guohong Shan, China Country Lead, Pfizer Innovative Health.
"We applaud the efforts of Chinese Government and the CFDA to bring new medicines to the Chinese healthcare system. Pfizer is committed to working closely with the CFDA, and will continue to partner with the Chinese government with the goal to help improve the lives of patients and people in China,” said Dr. Wu Xiaobin, country manager of Pfizer China.
The CFDA approval is based upon the efficacy and safety data from global RA pivotal study A3921046 China sub group, pharmacokinetics data from China PK study A3921065 and sufficient data from global RA pivotal studies including five phase III studies and a long-term extension study. The recommended dose of Xeljanz approved in China is 5 mg taken twice daily, orally with or without food.
Xeljanz (tofacitinib citrate) has been approved for use in over 50 countries.i Since Xeljanz was first approved in the U.S. in 2012, it has been prescribed to more than 90,000 patients worldwide.ii
In January 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending Xeljanz 5 mg twice daily (BID) for the treatment of patients with moderate to severe active RA. The CHMP’s opinion is now with the European Commission for final decision. In the European Union, Xeljanz is an investigational medicine and has not been approved for use.
Tofacitinib is included in a number of RA treatment recommendations, including those published by the Asia Pacific League of Associations for Rheumatology (APLAR), European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).
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 (tofacitinib citrate)/Xeljanz XR (tofacitinib citrate) extended-release is a prescription medicine called a Janus kinase (JAK) inhibitor. 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.