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FDA delays ruling on expanding use of Amarin's Vascepa; shares soar

  • The FDA has indefinitely delayed a ruling on Amarin's (AMRN) request to expand the use of of the company's Vascepa drug, which lowers triglyceride fat in blood.  Under the new "ANCHOR" indication, the therapy would be used to treat people who take statins to cut cholesterol and have a high risk of coronary heart disease.
  • The FDA was due to issue its verdict today, but the agency put off the ruling as it's still considering Amarin's request to re-instate the ANCHOR Special Protocol Assessment (SPA) agreement. Under the SPA, the FDA had said that the design of an uncompleted Phase III trial was acceptable to support a marketing application to widen Vascepa's use case.
  • However, the agency rescinded that SPA in October and initially denied Amarin's appeal over the matter.
  • The FDA has also said that it views that appeal as separate from the firm's request to expand the use of Vascepa.
  • Amarin shares are +32%. (PR)
Comments (7)
  • Rope a Dope
    , contributor
    Comments (611) | Send Message
     
    That is stunning news; good for AMRN.
    20 Dec 2013, 07:57 AM Reply Like
  • 2puttwo
    , contributor
    Comments (572) | Send Message
     
    Got 10% back- 90% to go. This has been a very heavy load to haul. I decided to go down with the ship, so this either delays my demise or let's me get to take a vacation this year.
    20 Dec 2013, 10:27 AM Reply Like
  • Rope a Dope
    , contributor
    Comments (611) | Send Message
     
    2putt, I hope you get to take your vacation. AMRN against the FDA is a David and Goliath story and although I thought they were doing the right thing by taking on the FDA, I never expected the FDA to budge. AMRN still has a long way to go but I think this move by the FDA is encouraging.
    20 Dec 2013, 10:51 AM Reply Like
  • ijo
    , contributor
    Comments (2) | Send Message
     
    I don't get it - why is this good news?
    20 Dec 2013, 11:41 AM Reply Like
  • Rope a Dope
    , contributor
    Comments (611) | Send Message
     
    ijo, I think before today everyone, including me, didn't think AMRN had any chance against the FDA decision.

     

    To borrow a quote from Jim Carrey - "So you're saying there's a chance"
    20 Dec 2013, 04:00 PM Reply Like
  • ControlledRisk
    , contributor
    Comments (285) | Send Message
     
    I hope someday a book is written about the inside process behind all this, perhaps even a movie. It seems to have everything, huge money at stake, corporate power plays, government corruption (or at least inept bureaucracy). All while the general public (investors and patients) gets stomped on.

     

    At this point I have accepted the disaster of my investment, and am just fascinated at the twists and turns this story takes while defying all reason and logic.
    20 Dec 2013, 03:13 PM Reply Like
  • foldholder
    , contributor
    Comments (92) | Send Message
     
    See more details:
    http://bit.ly/17K7jmv
    this is why FDA is reconsidering. amrn mgmt. itself has done a poor job with fda but thanks to the epa community fda should make right decision else face some serious outcomes.
    20 Dec 2013, 05:15 PM Reply Like
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