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

Galectin Therapeutics Submits Fast Track Application To FDA For GR-MD-02 In Treatment Of Fatty Liver Disease With Advanced Fibrosis

NORCROSS, Ga., July 1, 2013 /PRNewswire/ -- Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that it has submitted a Fast Track application to the FDA to help expedite its clinical development program of GR-MD-02 in the treatment of non-alcoholic steatohepatitis (NASH, or fatty liver disease) with advanced fibrosis. FDA grants Fast Track designation to help expedite review and approval of drugs in development that treat serious or life threatening diseases and fill an unmet medical need. GR-MD-02 has shown robust treatment effects in reversing fibrosis and cirrhosis in pre-clinical studies and a phase 1 clinical trial in patients with NASH with advanced fibrosis is currently enrolling.

"There are currently no approved medical treatments available for the millions of patients in the US who have NASH with advanced fibrosis," said Dr. Peter G. Traber, President, Chief Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. "Fast Track designation from FDA would effectively open many important regulatory pathways to efficiently expedite patient access and will be highly beneficial to advancing the development program for GR-MD-02 in the treatment of NASH with advanced fibrosis."

A drug that receives Fast Track designation is eligible for many regulatory benefits from the FDA that can lead to earlier drug approval and access by patients, including more frequent meetings and interactions with the Agency during development to ensure appropriate clinical design and data collection. Drugs receiving Fast Track status are also eligible for Rolling Review, Priority Review, and Accelerated Approval pathways. FDA's Rolling Review process allows a drug company to submit completed sections of its New Drug Application (NDA) for review rather than waiting until every section of the application is completed. Priority Review allows the FDA to reduce the time to review a new drug application, with a completion goal of six months from the 60 day filing date, as opposed to 10 months from the 60 day filing date for the current standard review. An Accelerated Approval pathway is an option for approval based on demonstrating an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit. For further information, please see http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm.

In accordance with "FDA Guidance for Industry: Fast Track Drug Development Programs —Designation, Development, and Application Review," the Agency will respond to a request for Fast Track designation within 60 calendar days of receipt of the request. A designation letter from FDA will help facilitate the development of GR-MD-02; the purpose of the Fast Track process being to get important new drugs to the patient earlier.

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
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 17,630.27 +189.68 1.09%
S&P 500 2,093.25 +25.61 1.24%
NASDAQ 5,089.2060 +49.43 0.98%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs