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.
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