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

Savient Pharmaceuticals Announces Publication Of Pivotal Phase III KRYSTEXXA® Data In JAMA Demonstrating Significant Benefits In Refractory Chronic Gout Patients

Stocks in this article: SVNT

EAST BRUNSWICK, N.J., Aug. 16, 2011 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today announced that results from two pivotal KRYSTEXXA® (pegloticase) Phase III clinical studies in patients with refractory chronic gout (RCG) have been published in The Journal of the American Medical Association ( JAMA). The data demonstrated that treatment with KRYSTEXXA resulted in significant and sustained reductions in uric acid levels along with clinical improvements in a substantial proportion of RCG patients for six months, a timeframe for demonstrating clinical improvement that is unique in randomized controlled studies of urate-lowering therapies.

The two replicate, randomized, double-blind, placebo-controlled Phase III studies were designed to evaluate the efficacy and tolerability of treatment with KRYSTEXXA 8 mg every two weeks or every four weeks compared to placebo for the management of RCG patients. Pooled results from these studies demonstrated that treatment with KRYSTEXXA every two weeks, the U.S. Food and Drug Administration (FDA)-approved dose, resulted in a statistically significant and sustained reduction in uric acid levels below 6 mg/dL in 42 percent of patients, compared to zero percent of patients receiving placebo (p<0.001).  

In addition, 40 percent of patients with tophi receiving KRYSTEXXA every two weeks experienced complete resolution of one or more tophi, which are deposits of crystalline urate in joints, skin or cartilage, by the final study visit, compared to seven percent of patients on placebo (p=0.002). A tophus complete response was defined as 100 percent reduction in the measured area of at least one tophus without growth of any baseline tophus or appearance of any new tophus.

"When effective lowering of uric acid levels cannot be achieved with oral medications, many gout patients progress to a severe form of the condition known as refractory chronic gout, which is characterized by frequent arthritic flares, chronic pain, physical disability and poor quality of life," said Michael A. Becker, M.D., Professor Emeritus of Medicine at The University of Chicago. "The data from these studies demonstrated that significant and rapid clinical benefits can be shown in such severely affected patients during KRYSTEXXA treatment."

Improved patient-reported outcomes in physical function, pain and quality of life were also observed in KRYSTEXXA-treated patients.

1 of 5

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 17,280.06 +88.69 0.52%
S&P 500 2,003.57 +1.41 0.07%
NASDAQ 4,631.28 -6.7140 -0.14%

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