Vascepa was intended to reduce Trigs, which it did, safely and effectively, whether or not that translates to improved outcomes is unknown at this time.
It should not be punished for not knowing the answer to outcomes, it does what it was asked to do, lowers Trigs and other Biomarkers, that is what it should be approved for with the label stating that no clinical outcome data is available to guarantee prevention of outcomes, but prevailing science feels that it is important to maintain healthy Trig and non-HDL-C levels.
AACE was begging the panel to approve. It should be approved for this indication.
Right now, Lovaza is the primary script written for ANCHOR patients, or off-label, and it comes with Atrial Fibrillation warnings and LDL-C raising concerns, neither of which Vascepa carries. Generic Lovaza could also be coming to market within a year or so, and that would likely be scripted to ANCHOR patients ahead of Vascepa for those Prescribers who don't understand all the details of the science and the warnings...
Is this what you want to see FDA? You have to be out of your mind, and you ask "What if's" What if REDUCE-IT shows no benefit? Yeah, well how about THIS WHAT IF! What if REDUCE-IT shows dramatic benefit??
WHAT IF REDUCE-IT SHOWS DRAMATIC BENEFIT!!! Then what do you say to all the Diabetic Mixed-Dyslipidemia patients who died while you held back a potential safe and effective LIFE SAVING THERAPY? WHAT IF?
Use your head and listen to the prevailing science of the likes of the AACE who have thoroughly researched their field and have recommended therapy like Vascepa for those in need, those at risk.
Disclosure: I am long AMRN.