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Chinese FDA approves Xeljanz for treatment of rheumatoid arthritis
The Chinese Food and Drug Administration has granted marketing approval to Pfizer China for 5-mg twice daily Xeljanz in the treatment of adults with moderate to severe rheumatoid arthritis and inadequate response or intolerance to methotrexate, according to a company press release.
Xeljanz (tofacitinib, Pfizer) — a Janus kinase (JAK) inhibitor approved in the United States in 2012 and currently awaiting a final decision in the European Union — can be used as combination therapy with methotrexate or another non-biologic disease-modifying antirheumatic drug.
“The introduction of the first oral JAK inhibitor for [rheumatoid arthritis] 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,” Guohong Shan, China County Lead at Pfizer Innovative Health, said in the release.
The approval, according to the release, is based on data from five phase 3 studies and one long-term extension study.
“We applaud the efforts of Chinese government and the [Chinese Food and Drug Administration] CFDA to bring new medicines to the Chinese health care system,” Wu Xiaobing, MD, Country Manager of Pfizer China, said in the release.
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