This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

XELJANZ® (tofacitinib Citrate) Approved In Japan For The Treatment Of Adults With Rheumatoid Arthritis (RA)

Pfizer Inc. (NYSE: PFE) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved XELJANZ ® (tofacitinib citrate) for the treatment of adults with rheumatoid arthritis (RA) who have had an inadequate response to existing therapies. XELJANZ may be used in patients in whom clinical symptoms due to the disease remain even after appropriate treatment with at least one other disease-modifying antirheumatic drug (DMARD), such as methotrexate. The recommended dose of XELJANZ is 5 mg twice daily.

XELJANZ will be commercially available in Japan after the National Health Insurance listing and will be co-promoted in Japan by Pfizer and Takeda Pharmaceutical Company Limited. Pfizer and Takeda also currently co-promote the RA drug Enbrel ® (etanercept) in Japan.

XELJANZ (ZEL’ JANZ’) is the first approved oral treatment in a new class of medicines known as Janus kinase (JAK) inhibitors. Initially, XELJANZ will be made available in Japan to medical institutions participating in an all-patient surveillance program.

“RA is a serious and disabling disease and there is a need for new treatment options, as a significant number of patients do not adequately respond to current therapies,” said Mark Swindell, Head of Pfizer Specialty Care Business Unit in Japan. “We are proud of our strong portfolio of treatments for inflammatory disorders in Japan, and we are pleased with the approval of XELJANZ, which allows us to offer an additional treatment option for RA patients.”

Unlike biologic therapies that target RA outside the cell, XELJANZ targets the disease from inside the cell. It is specifically designed to inhibit the Janus kinase (JAK) pathways, which are signalling pathways inside the cell that play a role in the inflammation involved in RA.

The approval of XELJANZ in Japan is supported by a multi-study, global clinical development program, which evaluated XELJANZ in approximately 5,000 patients across various RA patient populations. The application also included data from Japanese subjects from two phase 2 studies, one phase 3 study and an ongoing long-term extension study. Across five global pivotal trials, XELJANZ 5 mg twice daily demonstrated efficacy, whether administered alone or in combination with a non-biologic DMARD, such as methotrexate, in patients who had a previous inadequate response to non-biologic or biologic DMARDs, including tumor necrosis factor (TNF) inhibitors.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.99 0.31%
FB $102.01 0.10%
GOOG $682.40 -0.10%
TSLA $151.04 0.38%
YHOO $27.04 1.05%


Chart of I:DJI
DOW 15,973.84 +313.66 2.00%
S&P 500 1,864.78 +35.70 1.95%
NASDAQ 4,337.5120 +70.6750 1.66%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs