Move over Vascepa, here comes Epanova


The FDA approves AstraZeneca's (AZN) Epanova (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (>=500 mg/dl). It is the first approved omega-3 in free fatty acid form. Patients can take as few as two capsules/day.

In some patients Epanova increases LDL-Cholesterol so this parameter should be monitored periodically during therapy. This will undoubtedly be a selling point for Amarin's (AMRN) Vascepa (icosapent ethyl) since it lowers LDL-C.

(OMTH)

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Comments (7)
  • steppppo
    , contributor
    Comments (250) | Send Message
     
    Nice. Now, we just need the exclusivity determination to be reached by September 30, 2014 for the first milestone payment. At least, I think that's what we're waiting for.
    6 May 2014, 09:16 AM Reply Like
  • ralphey
    , contributor
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    Yea move over for a product that has that raises ldl - dont think so !
    6 May 2014, 12:42 PM Reply Like
  • stevie.atl
    , contributor
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    Interesting. So if, as the FDA claimed with Amarin’s rejected attempt at label expansion, there is no evidence that lowering TGs reduces CV events, why is the FDA approving yet another fish oil medication that lowers TGs???
    6 May 2014, 01:26 PM Reply Like
  • Not_Quite_Pheidippides
    , contributor
    Comments (387) | Send Message
     
    Very high triglycerides increase the risk of pancreatitis. That's essentially why the FDA will keep approving TG-lowering drugs for the MARINE population, but not ANCHOR (those levels not well associated with pancreatitis, I believe, but correct me if I'm wrong).
    8 May 2014, 10:43 AM Reply Like
  • stevie.atl
    , contributor
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    Perhaps that's the reason, but as far as I know, these products aren't marketed as a treatment or prevention for pancreatitis. It seems to me that the same specious arguments the FDA made against Vascepa's label expansion and in the inexplicable rescinding of the Anchor SPA should apply equally to the approval decision for Epanova....if the FDA operated on the basis of consistency, which they clearly do not.
    8 May 2014, 12:10 PM Reply Like
  • mitrado
    , contributor
    Comments (2033) | Send Message
     
    The FDA only cares about the big multinationals and that's why I've stopped trading biostocks. No point in betting against "the house."
    9 May 2014, 06:22 AM Reply Like
  • mitrado
    , contributor
    Comments (2033) | Send Message
     
    FDA corruption proved once again.
    7 May 2014, 03:31 PM Reply Like
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