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 The leading web portal for pharmacy resources, news, education and careers April 24, 2017
Pharmacy Choice - Pharmaceutical News - Pfizer Announces Approval By The China Food And Drug Administration Of XELJANZ, The First Oral JAK Inhibitor For Adult Patients With Moderately To Severely Active Rheumatoid Arthritis [Sudan Tribune] - April 24, 2017

Pharmacy News Article

 3/18/17 - Pfizer Announces Approval By The China Food And Drug Administration Of XELJANZ, The First Oral JAK Inhibitor For Adult Patients With Moderately To Severely Active Rheumatoid Arthritis [Sudan Tribune]

Pfizer China announced today that it 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 Pfizers 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.



(c) 2003-2017 SudanTribune - All rights reserved. Provided by SyndiGate Media Inc. (Syndigate.info).

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