More on FDA - Amarin

Under the FDA's special protocol assessment (SPA) for the Anchor indication of Amarin's (AMRN) Vascepa treatment, the agency had said that the design of the associated Phase III trial was adequate to support a marketing application to broaden the use of the drug, which lowers triglyceride fat in blood.

The study was testing Vascepa in people who take statins to cut cholesterol and have a high risk of coronary heart disease. Vascepa is already used to reduce triglycerides in patients who don't take statins.

The FDA is due to decide by December 20 whether to widen the authorization of Vascepa. However, given the latest developments and that an FDA advisory committee overwhelmingly voted against such approval, things are not looking promising.

Shares continue to tank and are -17.5%. (Previous) (8K)

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Comments (8)
  • mangum
    , contributor
    Comments (71) | Send Message
    FDA, for sale to highest bidder.
    22 Nov 2013, 07:47 AM Reply Like
  • SimonSaysShort
    , contributor
    Comments (116) | Send Message
    The FDA is for sale because Vascepa did not show compelling evidence that it reduces CVs? Interesting...
    22 Nov 2013, 07:58 AM Reply Like
  • ganj1948
    , contributor
    Comments (9) | Send Message
    The Anchor SPA was not for reducing CV's. The SPA required the outcomes study, Reduce-It to be substantially underway. Since this condition was met, the FDA should have worded the AdCom question to reflect this, not whether Anchor provided proof of reducing CVs.
    22 Nov 2013, 03:37 PM Reply Like
  • Black Gold
    , contributor
    Comments (793) | Send Message
    People were crazy for even thinking AMRN would get a successful appeal. Obviously, the FDA wants to see Reduce-It before approving Anchor. The direction the FDA panel nudged the panel showed that, the panel results showed that, and withdrawing the SPA only confirmed it.


    Folks who bought on JoeZ's insignificant purchase deserved to lose their money. $80,000 is not a lot for a man who made millions selling the same stock a year earlier. Clearly a PR move.
    22 Nov 2013, 07:58 AM Reply Like
  • Quoth the Raven
    , contributor
    Comments (2063) | Send Message
    Nobody realistically expected them to grant the appeal:
    22 Nov 2013, 08:01 AM Reply Like
  • QInv
    , contributor
    Comments (31) | Send Message
    The FDA has not accepted the appeal on PROCEDURAL ground and has not adjudicated on the merit. This is a normal process when any agency / forum is operated with guidelines and rules ... to create fairness among people / entities working with the agency. While the appeal (and for that matter, the fight for ANCHOR) is a difficult, uphill battle from the beginning, outside experts and specialists have advised to appeal given the compelling facts of the case. Hurdles -- challenging and frustrating -- have been and to be expected. No one assumes that it would be a walk in the park. Nevertheless, given the compelling set of facts in this case, there is a good chance that AMRN will prevail. We shall see.
    22 Nov 2013, 09:00 AM Reply Like
  • gatlingg
    , contributor
    Comments (380) | Send Message
    If AMRN was fighting to gain approval for using vascepa for folks in this level who are not using statins they might prevail BUT they are seeking approval to use vascepa in conjunction with statins. And IF I remember the labeling they are seeking It basicly indicates that the use of both will likely result in less CV events (at least that was my interpretation as I remember it, I could be abit off here).
    I believe AMRN management is focused on the FDA granting approval for use of vascepa with statins, a foolish endeavor at this time. It is time to get real and seek approval for those not on statins; such approval wouldn't preclude MD's from prescribing it for those on statins.
    22 Nov 2013, 03:27 PM Reply Like
  • foldholder
    , contributor
    Comments (89) | Send Message
    going to the court is the only way to get justice... with the millions earned by JZ he should use that money to pay for the court...
    24 Nov 2013, 11:35 AM Reply Like
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