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Isis Pharmaceutical (ISIS -3.6%) shares slip lower despite the FDA's announcement that it's...

Isis Pharmaceutical (ISIS -3.6%) shares slip lower despite the FDA's announcement that it's recommended approval of Kynamro for the treatment of Hypercholesterolemia, as analysts dig deeper into the recommendation's details, which the FDA is not required to follow. Jefferies notes that the approval could be "very limited," while a Seeking Alpha report suggests that competitor Aegerion Pharma's (AEGR -5%) Lomitapide could be a better choice, with a more decisive vote from the committee and none of the safety concerns of Kynamro.
Comments (3)
  • SeekingValue
    , contributor
    Comments (160) | Send Message
     
    As the author of the Seeking Alpha report you cite, I have to disagree with the assertion that Lomitapide has "none of the safety concerns of Kynamro." It actually has exactly the same liver toxicity safety concerns, plus nutrient absorption issues. It just doesn't have the suggestions of possible carcinogenicity that came up in Kynamro discussions.
    19 Oct 2012, 01:09 PM Reply Like
  • brown25
    , contributor
    Comments (63) | Send Message
     
    I agree 100% with you . AEGR has as many if not more issues that were "glossed "over in the panel hearing ( I still don't understand that one). They had deaths and tumors in the trial that were skipped over in the discussion. I listened to both of the hearings.
    19 Oct 2012, 01:30 PM Reply Like
  • arthurs1
    , contributor
    Comments (355) | Send Message
     
    Nonsense, AEGR has liver issues, in fact a higher % of patients had to discontinue the trial because more of them were > 5x ULN. Also it is very likely to cause major GI problems.
    Isis' patients on average were sicker to begin with, much higher LDL-C levels.
    AEGR had 23 patients finish trial and titrated (adjusted dosage) as they saw fit. ISIS/Genzyme trials was not allowed to do this and have aprox 500 patients.
    SA can be as misinformative as it is informative.
    19 Oct 2012, 01:16 PM Reply Like
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