Pfizer's Xeljanz Gets Chinese FDA Nod

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 diseasemodifying 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.