Join        Login             Stock Quote

Pfizer (PFE): FDA OKs Rheumatoid Arthritis Treatment Pill

 November 07, 2012 01:16 PM

(By Balachander) Pfizer Inc. (NYSE: PFE) said the U.S. Food and Drug Administration (FDA) approved its Xeljanz to treat rheumatoid arthritis (RA).

The U.S. health regulators approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate.

According to the Centers for Disease Control and Prevention, RA affects an estimated 1.5 million Americans.

Xeljanz, a pill taken twice daily, works by blocking molecules called "Janus kinases," which are important in the joint inflammation of RA.

[Related -Pfizer Inc. (PFE) Q3 Earnings Preview: What To Watch?]

"Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate," said Badrul Chowdhury, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

The FDA approved Xeljanz ahead of the product's prescription drug user fee goal date of Nov. 21, 2012.

In seven clinical trials in adult patients with moderately to severely active RA, patients treated with Xeljanz experienced improvement in clinical response and physical functioning compared to patients treated with placebo, the FDA said.

The most common adverse reactions in clinical trials were upper respiratory tract infections, headache, diarrhea, and inflammation of the nasal passage and the upper part of the pharynx.

[Related -Six Stocks That Could Get An October Bump From The FDA]

"We are proud of the comprehensive data that support the use of XELJANZ, and we are excited to make it available to patients in the U.S. as a powerful oral option that can be taken as a second-line treatment with or without methotrexate," said Geno Germano, president and general manager, Specialty Care and Oncology, Pfizer.

Shares of the New York-based company traded 0.57 percent lower at $24.35 on Wednesday.

iOnTheMarket Premium


Post Comment -- Login is required to post message
Alert for new comments:
Your email:
Your Website:

rss feed

Latest Stories

article imageLong-term Relationships and Credit Scores

Unlike many commentators, I tend to think credit scores are a good read on...

article imageIn Defense Of Rolling Return Charts

Robeco’s Lukas Daalder has a bit of an issue with rolling-performance graphics. Bashing a recent chart of read on...

article imageThe S&P 500’s Worrisome Downturn In Drawdown

Last Friday I reviewed some of the bearish signals that were casting dark shadows across the US stock read on...

article imageADP: Private-Sector Employment Rises A Solid 200k In September

The pace of growth for private-sector employment picked up in September, according to this morning’s ADP read on...

Popular Articles

Daily Sector Scan
Partner Center

Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.