Well, according to the FDA panel, having a successful REDUCE-IT trial is unlikely. Fenofibrates already are approved for the 200-500 mg/DL indication yet they have not shown significant heart benefit in every study, so Vascepa is likely to do the same, or so the logic goes. V vs. fibrates is interesting in that V has fewer side effects and the only large long term scientific trial showing heart benefit with statins, (JELIS). The only reason Lovaza didn't get the 200-500 market was because of the raise in LDL-C on statins, and then a failed trial showing it actually can lead to atrial fibrulation. But L would have had the indication had it done what V does, and that is not raise LDL-C on statins, in fact, that WAS the requirement for ANCHOR until the FDA changed the goalposts at the last second. Niaspan is just a mess, but is still prescribed widely in the 200-500 mg/DL camp. Even Dr. Nissen still prescribes it to patients he thinks show some benefit, (although not to new patients). Forgotten in ALL of this is that Vascepa patients seem to enjoy their drug way more as opposed to all the others. Improved mood, reduction in joint pain, elimination of dry eye syndrome, and all manner of help for other inflammatory problems are things Vascepa does all the time. None of this helps investors who lost their life savings here, like me, but it does show that the FDA is not considering the bigger picture. The denial of Vascepa into ANCHOR was a disgraceful act, almost certainly brought on by pressure from BP and not the science or patients needs.
The patient experience is what has been missing from the entire story of V. Why didn't their marketing dept get patients to tell their story and successes with V. Less inflammation, reduced joint pain and discomfort, 'I now use 1/2 my statin dose and have improved markers'.......and the testimonials go on.
So, where are they ?
The FDA plays for free and makes the rules. I finally took my 2013 tax loss as many others will probably do.
Amarin has some intrinsic value in intellictual property, the one approved indication and possibly the Reduce It trial which is now needed by any entity that wants to bring a new TG lowering drug to the FDA. I still like the Omega 3 science as the effects are born out by population studies not just FDA rules. The problem is since Amarin completed the Anchor trials the nexus between TG lowering and ultimate lowering of CVD has been
thrown into the arena and the next shoe to drop may well be insurance plans ditching such drugs from their formulary.