Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Pfizer’s Xeljanz Oral JAK Inhibitor Okayed by China’s FDA

By Pfizer Inc. | March 17, 2017

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.

Pfizer China announced 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 who have had an inadequate response or intolerance to methotrexate. It may be used in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs.

Xeljanz is the first JAK inhibitor approved for rheumatoid arthritis 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 rheumatoid arthritis.

“The introduction of the first oral JAK inhibitor for RA (rheumatoid arthritis) 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 rheumatoid arthritis pivotal study A3921046 China sub group, pharmacokinetics data from China PK study A3921065 and sufficient data from global rheumatoid arthritis 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.ii
___________________________________________________

References:

i Pfizer Data on File. XELJANZ Worldwide Registration Status 2016.
ii Pfizer Data on File. XELJANZ Patient Experience Jan 26.

(Source: Business Wire)

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE