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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

FDA Advisory Committee Recommends Approval Of Lomitapide For Treatment Of Homozygous Familial Hypercholesterolemia (HoFH)

Stocks in this article: AEGR

CAMBRIDGE, Mass., Oct. 17, 2012 (GLOBE NEWSWIRE) -- Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat debilitating and often fatal rare diseases, announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) determined by a vote of 13 to 2 that Aegerion has presented sufficient safety and efficacy data to support marketing of its product, lomitapide, for the treatment of patients with Homozygous Familial Hypercholesterolemia (HoFH) when used as an adjunct to a low-fat diet and other lipid-lowering therapies.

"Today's Advisory Committee recommendation is an important milestone in our mission to provide patients with HoFH with urgently needed new treatment options to lower their cholesterol levels," said Marc Beer, Chief Executive Officer of Aegerion Pharmaceuticals. "We look forward to continuing to work closely with the FDA as the agency completes its review of our new drug application for lomitapide."

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of December 29, 2012, for completion of its review of the New Drug Application (NDA) for lomitapide. The EMDAC provides the FDA with independent expert advice and recommendations. The FDA is not bound by the EMDAC's recommendation, but will consider the committee's recommendation as the FDA completes its review of the lomitapide NDA.

Conference Call Details

The Aegerion management team will hold a conference call with the investment community to discuss the outcome of the EMDAC meeting today at 7:00 pm EDT. To listen to the live conference call, dial (866) 516-3002 (International callers dial (760) 298-5082). In addition, the conference call will be available through a live audio webcast in the " Investors" section of the Aegerion website, www.aegerion.com . The conference call will be archived and accessible on the same website shortly after the conclusion of the call.

About Lomitapide

Lomitapide is a microsomal triglyceride transfer protein (MTP) inhibitor that Aegerion is developing as a once-day capsule for the treatment of patients afflicted with certain severe lipid disorders, including HoFH. MTP exists in both the liver and intestines where it plays a role in the formation of lipoproteins containing cholesterol and triglycerides. Inhibiting MTP reduces the level of cholesterol that the liver and intestines assemble and secrete into the bloodstream. Currently, there is no MTP inhibitor approved by the FDA for any indication.

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 17,356.87 +288.00 1.69%
S&P 500 2,012.89 +40.15 2.04%
NASDAQ 4,644.3120 +96.4780 2.12%

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