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

CSL Behring Receives FDA Approval To Expand The Indication For Corifact®

KING OF PRUSSIA, Pa., Feb. 28, 2013 /PRNewswire/ --  CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact ®, Factor XIII Concentrate (Human), to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII (FXIII) deficiency. In 2011, Corifact became the first and only FXIII concentrate approved in the U.S. for the routine prophylactic treatment of congenital factor XIII deficiency.

Congenital FXIII deficiency is a rare and potentially life-threatening bleeding disorder in which blood clots normally, but the clots formed are unstable, leading to recurrent bleeding. It is estimated that the condition affects one person in two million, with prevalence in the U.S. of approximately 150 people.

The expanded indication is based on use of Corifact in peri-operative situations as part of both a 12-month, prospective, open-label, multicenter efficacy and safety study as well as a nine-year investigator-initiated clinical study. In total, 20 patients received peri-operative management with FXIII. Neither treatment-related adverse events nor investigator-assessed serious adverse events were reported.  

The post-marketing commitment trial further supports the safe and effective use of Corifact in the clinical setting and fulfills CSL Behring's post-marketing commitment, under the FDA's accelerated approval regulations, for Corifact.

"FDA's decision to approve Corifact for management of peri-operative bleeding in people with congenital factor XIII deficiency is an important advance that illustrates CSL Behring's ongoing commitment to those with rare and serious medical conditions who rely on our lifesaving therapies," said Lynne Powell, Senior Vice President, North America Commercial Operations, CSL Behring.

About Corifact ® Corifact, an intravenous (IV) infusion given approximately every 28 days, is indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency. Corifact is a fibrin-stabilizing factor concentrate that provides both A- and B-subunits to protect against FXIII deficiency. Clinical studies have shown that Corifact immediately increases FXIII levels in the blood. Corifact is dosed, depending on the patient's weight, to maintain trough FXIII levels between 5 and 20 percent of normal.

Corifact is packaged as lyophilized powder in a single-use vial with high stability and a long shelf life. The concentrate is stable for up to six months at room temperature (25 degrees C) and 24 months when refrigerated (2-8 degrees C). Corifact also has a low infusion volume, which could help reduce administration time.

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 $94.48 -0.56%
FB $99.24 -0.51%
GOOG $678.11 -0.68%
TSLA $150.16 1.50%
YHOO $26.75 -1.10%


Chart of I:DJI
DOW 15,945.62 -81.43 -0.51%
S&P 500 1,844.60 -8.84 -0.48%
NASDAQ 4,260.4290 -23.3240 -0.54%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs