This Day On The Street
Continue to site
ADVERTISEMENT
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

Pfizer Provides Update On Global Regulatory Approvals And Launches Of XELJANZ® (tofacitinib Citrate) For The Treatment Of Rheumatoid Arthritis

Pfizer Inc. (NYSE: PFE) announced today that tofacitinib has been approved for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to existing therapies in several additional countries around the world, including Switzerland, which is the first European country to receive approval. Swissmedic, the Swiss agency for therapeutic products, approved tofacitinib 5 and 10 mg twice-daily (BID) as monotherapy or in combination with a disease modifying non-biologic antirheumatic agent (DMARD), including methotrexate (MTX), in adult patients with moderate-to-severe active RA who have had an inadequate response or intolerance to MTX. Tofacitinib 5 mg BID has also been approved in Argentina, Kuwait and the United Arab Emirates, and tofacitinib 5 mg and 10 mg BID has been approved in Russia. The brand name for tofacitinib in the approved markets will be XELJANZ, except for Russia, where the brand name will be Jaquinus ®.

As previously announced, XELJANZ 5 mg BID is also approved in the United States and Japan for the treatment of moderate-to-severe active RA. XELJANZ was launched in the United States in November 2012, and XELJANZ is expected to be commercially available in Japan this month following approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) in March 2013. XELJANZ will be co-promoted in Japan by Pfizer and Takeda Pharmaceutical Company Limited. Initially, XELJANZ will be made available in Japan to medical institutions participating in an all-patient surveillance program, designed by Pfizer in collaboration with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and the Japan College of Rheumatology.

“More than 23 million people worldwide are living with rheumatoid arthritis and there remains an unmet need for additional treatments, with up to one-third of RA patients not adequately responding and about half who stop responding to any particular DMARD within five years,” said Geno Germano, president and general manager, Specialty Care and Oncology, Pfizer. “XELJANZ has a novel mechanism of action for the treatment of moderate-to-severe RA. With these approvals, we believe XELJANZ has the potential to change the way rheumatologists treat this chronic, and potentially disabling, disease, and we are proud to offer patients and physicians an additional treatment option.”

1 of 4

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
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

Chart of I:DJI
DOW 17,689.86 -56.12 -0.32%
S&P 500 2,103.84 -4.79 -0.23%
NASDAQ 5,128.2810 -0.5040 -0.01%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs