Pfizer China, a unit of Pfizer Inc. (PFE), said it has received approval from the Chinese Food and Drug Administration or CFDA to market its oral Janus kinase (JAK) inhibitor, Xeljanz or tofacitinib citrate, in China for the treatment of adult patients with moderately to severely active rheumatoid arthritis or RA, who have had an inadequate response or intolerance to methotrexate (MTX).
Xeljanz may be used in combination with MTX or other non-biologic disease-modifying antirheumatic drugs or 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 Guohong Shan, China Country Lead, Pfizer Innovative Health.