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Amarin Corporation plc Message Board

  • mexinv mexinv Oct 12, 2013 12:14 AM Flag

    From Allen Brzozowski โ€@ajbrzski twit - FDA Briefing Doc points to positive AdCom - P. 103-104 par attached.

    Last paragraph in Briefing Doc,pp103-104,points to positive AdCom. The mineral oil discussion is ridiculous!
    Vascepa offers advantages over existing TG-lowering therapies. One of key benefits of Vascepa therapy is the absence of a significant increase of LDL-C, since fibrates and omega acid complex mixtures that contain EPA+DHA are known to increase LDL-C levels in hypertriglyceridemic patients (Goldberg 1989, Bays 2008). A further benefit of Vascepa therapy is that it does not interfere with glucose control. While small numerical elevations were see in FPG, they were not statistically significant or clinically meaningful. The more accurate markers of glucose control (insulin, HbA1c, HOMA-IR) were similar between active and placebo arms.
    Patients who are at high risk for CVD who are taking statin therapy and have persistently
    Vascepa (icosapent ethyl) Capsules
    Briefing Materials for EMDAC
    October 16, 2013
    high TGs are at-risk and need a safe and effective therapy that can be added to their statin therapy for more aggressive and comprehensive lipid control. If approved, Vascepa would fill an important unmet medical need for these patients.

    Sentiment: Strong Buy

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