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
$1 buys you full access to ALL of TheStreet's Subscription Services! Learn More

Medical Imaging Drugs Advisory Committee Recommends Approval Of Guerbet NDA For Dotarem® (gadoterate Meglumine)

VILLEPINTE, France, Feb. 14, 2013 /PRNewswire/ -- Guerbet, the contrast agent specialist for medical imaging, today announced that the Medical Imaging Drugs Advisory Committee to US Food and Drug Administration (FDA) has voted unanimously by votes of 17 to 0 to recommend that FDA approve the New Drug Application (NDA) for Dotarem® (gadoterate meglumine) for adults, and for pediatric use for children two years of age and older. The Committee voted 10 to 6 (with one member abstaining) not to recommend at this time approval of the indication for children under two years of age.

Dotarem® is the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) for the intravenous use with magnetic resonance imaging (MRI) in the brain (intracranial), spine and associated tissues in adults and pediatric patients to detect and visualize areas with disruption of the blood-brain barrier (BBB) and/or abnormal vascularity. The Guerbet NDA recommended dose is 0.1 mmol Gd/kg.

"Guerbet is very pleased with the Advisory Committee's recommendation to approve Dotarem® based on our comprehensive presentation of clinical and post-marketing data," said Yves L'Epine, CEO of Guerbet Group.  "If approved by FDA, we believe Dotarem can provide another CNS imaging option for US clinicians. We are disappointed that the recommendation does not include the indication for children under two years of age, but we take the Committee's comments very seriously and will work to address all FDA questions and concerns."

The Dotarem® data presented at today's advisory committee meeting included results from two well-controlled Phase III clinical studies. These studies evaluated the diagnostic efficacy of Dotarem® in magnetic resonance imaging of diseases of the central nervous system, such as primary or secondary tumors of the brain or spinal cord, inflammatory diseases such as multiple sclerosis and vascular brain diseases.

Both studies evaluated the superiority of the enhanced images over the unenhanced images for central nervous system (CNS) lesion visualization in all three co-primary endpoints. All defined primary and key secondary efficacy analyses were met and support the efficacy of Dotarem® at a standard dose of 0.1 mmol/kg BW.  In addition to these two studies, 21 supportive clinical studies evaluated the efficacy of Dotarem-enhanced MRI.

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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 17,828.24 +0.49 0.00%
S&P 500 2,067.56 -5.27 -0.25%
NASDAQ 4,791.63 +4.3130 0.09%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

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