The only reason someone would be taking Vascepa in this scenario is to reduce the risk for cardiovascular disease. “, “to target this lower range of TG, it was clearly with the goal of selling it to reduce the risk for cardiovascular disease …. Although the indication strictly speaks to reduction in lipoprotein levels and improvement in numbers, this indication for this population certainly implies that one should expect cardiovascular benefit from treatment”
AMRN said: “DR. KETCHUM: Yes. We factored in existing labels from other lipid-lowering therapies in terms of the types of parameters mentioned in their indication statements and/or in the data tables within the label. So that was the rationale for the proposed indication. Obviously, the application is still under review. We need to dialogue with the FDA team in terms of ultimately arriving at the label. But the hierarchy of the importance is clearly triglycerides without impacting LDL, and non-HDL-C.
FDA says indication (label) is strictly lipids and perhaps secondary endpoints, Ketchum says "Yes" - so how/when did CVE on label, which is R-IT label, get into the equation? Also, why would "not proven to reduce CVE" get a BBW, which is typically reserved for serious adverse effects or contraindications? Why wouldn't it be listed exactly as it is on the MARINE label?
It is not known if VASCEPA changes your risk of having inflammation of your pancreas (pancreatitis).
It is not known if VASCEPA prevents you from having a heart attack or stroke.
It is not known if VASCEPA is safe and effective in children.
The Thought Police: To censor and protect. Craig Bruce
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