This Day On The Street
Continue to site right-arrow
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
TheStreet Open House

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

Stocks in this article: PFE

Regulatory applications for XELJANZ for the treatment of moderate-to-severe active RA remain under review in more than 30 additional countries. In Europe, Pfizer is seeking a re-examination of the Committee for Medicinal Products for Human Use (CHMP) negative opinion that was announced in April, and the company is currently working with the CHMP on the next steps in the process.

XELJANZ is the first approved RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors. The recent marketing authorizations for XELJANZ were based on data from the comprehensive, global, multi-study clinical development program for XELJANZ, which included approximately 5,000 patients in more than 40 countries, resulting in 7,000 patient-years of experience at the time of regulatory submission.

Important Safety Findings for XELJANZ

Notable safety findings observed in the XELJANZ RA program include serious and other important infections, including tuberculosis and herpes zoster; malignancies, including lymphoma; gastrointestinal perforations; decreased neutrophil and lymphocyte counts; and lipid elevations. The most common serious adverse events were serious infections. The most commonly reported adverse events were upper respiratory tract infections, headache, nasopharyngitis and diarrhea.

About Rheumatoid Arthritis

Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. RA can be painful and disabling, 1 causing swelling, stiffness and loss of function in the joints. 1 RA affects 23.7 million people worldwide, 2 and although multiple treatments are available, up to one-third of patients do not adequately respond, and about half stop responding to any particular DMARD within five years. 3,4,5,6,7,8 As a result, there remains a need for additional options.

About XELJANZ

XELJANZ is a novel, oral Janus kinase (JAK) inhibitor for the treatment of RA. Unlike recent therapies for RA, which are directed at extracellular targets such as pro-inflammatory cytokines, XELJANZ takes a novel approach targeting the intracellular pathways that operate as hubs in the inflammatory cytokine network.

2 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,437.27 -241.43 -1.37%
S&P 500 2,036.39 -20.70 -1.01%
NASDAQ 4,709.0650 -62.6980 -1.31%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs