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
See Cramer's multi-million dollar portfolio for FREE and get his new book Get Rich Carefully! Learn More

As If Amarin Needs Another Worry, Here Comes A Vascepa FDA Panel

BEDMINSTER, NJ (TheStreet) -- Amarin (AMRN) President John Thero made news -- and not necessarily the good kind -- at an investor conference Thursday when he said the company was preparing for a Vascepa FDA advisory panel later this year.

A date for the FDA advisory panel has not been set, but Thero said the panel would review Amarin's prescription-grade fish oil pill for the so-called "Anchor" indication of treating patients with mixed dyslipidemia.

"There is an SNDA PDUFA date of December 20. Again, we are preparing for an advisory committee for that because it is the product that will be first in this indication for this class," said Thero, speaking at a healthcare investor conference Thursday sponsored by Jefferies.

I follow Amarin pretty closely but I can't recall executives discussing an FDA advisory panel for Vascepa in a public setting previously. This sounds like news to me.

In a research note dated April 8 following a meeting with Amarin management, J.P. Morgan analyst Chris Schott mentioned the possibility of an FDA panel for Vascepa.

Amarin bears (and yes, I'm one) believe FDA is wary of approving Vascepa for the larger mixed dyslipidemia patient population without definitive proof that the fish oil reduces the risk of heart attack, strokes and other cardiovascular events. The company is conducting a large cardiovascular outcomes trial of Vascepa, dubbed Reduce-It, but results won't be known until 2016.

An FDA advisory panel for Vascepa is a big risk for Amarin because experts could easily side with Cleveland Clinic cardiologist Dr. Steve Nissen, who opposes FDA approval of Vascepa's label without positive data from the Reduce-It study.

A Vascepa FDA panel later this year would convene with the torturous debate over the safety of the GlaxoSmithKline (GSK) diabetes drug Avandia still fresh in everyone's minds. A desire to avoid another Avandia or Merck's (MRK) Tredaptive is an argument for not expanding Vascepa's use without the cardiovascular outcomes data expected in 2016.

Amarin bulls believe FDA will approve Vascepa for the Anchor indication because the application and the Reduce-It study are covered under a Special Protocol Assessment agreement. But if that were true, why would FDA bother with convening an advisory panel?

Thero did not mention anything about a date for the Vascepa advisory panel during his presentation Thursday. FDA's endocrine division reviewed the original Vascepa approval application last year, but there are no tenative meeting dates for the Endocrinologic and Metabolic Drugs Advisory Committee scheduled for the rest of the year.

FDA could decide to have Vascepa reviewed by the Cardiovascular and Renal Drugs Advisory Committee, which has a tentative meeting scheduled for Aug. 5-7.

FDA could, of course, set up a meeting for the fall for either panel that is not currently on the agency's calendar.

-- Reported by Adam Feuerstein in Boston.

Stock quotes in this article: AMRN, GSK, MRK 
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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.
DOW 16,436.92 +28.38 0.17%
S&P 500 1,868.09 +3.24 0.17%
NASDAQ 4,102.6970 +7.1810 0.18%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

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