Here is the problem: Amarin is asking the FDA to allow them to sell Vascepa to the public as a product that WILL BENEFIT THEM by improving their health (lowering cv events). The problem is that the ANCHOR indication has not been shown to translate into health benefits. Amarin MUST show that ANCHOR usage reduces cardiovascular events FIRST.
The thing the committee will discuss (that should worry all of us) is NOT Vascepa's safety and effectiveness. Because that was demonstrated with ANCHOR.
The scary thing is with Trig levels 200-499mg, nobody has demonstrated the reduction of cardiovascular events that needs to be demonstrated before the FDA will approve a new drug/chemical entity to be sold to the general public for health benefit purposes. If Vascepa wasn't interested in selling Vascepa to people with Trig levels 200-499mg for HEALTH reasons, then the FDA would tell Amarin to sell it to whoever they want for any reason (non-health related). That is what PLUS-EPA is.
If the Advisory Panel spends too much time talking about the lack of health benefits of lowering Trig levels 200-499mg then it will be a no vote for sure. I imagine it will be a split no vote, but NO nonetheless. And the FDA which was probably considering lack of health benefits from the consumption of Vascepa already will be completely against approving Vascepa for these people.
They will want SOME proof that Vascepa is benefiting their HEALTH and so far, Amarin does not have anything showing that it does translate into health benefits.
I'm afraid their first question will be......WHAT HEALTH BENEFITS does Vascepa offer??? and WHERE IS AMARIN'S PROOF?
WHY would the panel recommend a "chemical entity" that is newly being presented to the FDA if its USE does not translate into lower CV EVENTS?
Vascepa lowers trigs, but does what does that mean in terms of HEALTH BENEFITS?
Only REDUCE-IT can tell us.
Drug approvals are at least partially covered by user fees and such programs (like Post Office) presumably not fully affected.
So far, we seem to have a bunch of "The Street" fear mongering and no specific or tangible basis as to what might happen.
"Here is the problem: Amarin is asking the FDA to allow them to sell Vascepa to the public as a product that WILL BENEFIT THEM by improving their health (lowering cv events)."
There you go again, trying to add apples and oranges.
The SPA says nothing about improving health. The subject of the binding SPA contract between Amarin and the FDA is lipid management. The panel will be asked to vote on whether they believe Vascepa is effective in lipid management and whether the safety profile is acceptable. It's really that simple not that the Reduce-It stipulation is put to bed.
Hey idiot, you may fool a scientific illiterate like AF, but not a board full of medical professionals. High TGs raise relative risk for CVD by 32% for men and 75% for women per 88.5 mg/dl increase of TG. This has been known for 20+ years; just search pubmed.
Lower TG = Lower CVD. V = Lower TG. V = Lower CVD. Go create another worthless ID, you have zero cred here.
Where do these idiots come from? V's indication is to lower TG, because no one should spend millions reinventing the wheel trying to prove lowering TG reduces CVD. If we want V's indication to include reducing CVD, hence REDUCE-IT. That's why BP keeps studying statins to add prevention of CVD to their label even when we all know reducing LDL reduces CVD. Got it?
Great, then there is no need for REDUCE-IT!
We all have been wasting our time and money!
Somebody call Amarin and tell them to stop the Reduce-it trial because gawaine43 says he has all the proof that is needed regarding CVD and Triglycerides.
You are the best!
How is it that nobody has yet explained to you that you are a dumb person? Do you ask people not to tell you? Do they not tell you because they feel sorry for you?
The JELIS study did not show statistically significant results In patients with no history of coronary artery disease. That is a problem.
In patients with a history of coronary artery disease, major coronary events were reduced by a measurement that was just barely statistically significant. This shows some promise.
Reduce-It will help distinguish statistical significance versus insignificance and anomalies.
As long as the narrow margin that was met in patients with a history of coronary artery disease, does not turn out to be a statistical anomaly or worse yet, a failure on the testing process for JELIS.
Some believe that further studies could possibly show health benefits after taking Vascepa.
Amarin is banking on it. If Reduce-It doesn't prove health benefits, then Amarin is going to be dumping their Vascepa down the sewer drains by the barrel full.
You have to look at the subgroup in Jelis that had high TG's combined with low HDL ...there the benefit was a 53% reduction in events
High TG's with high LDL cholesterol OR high TG;s with low HDL cholesterol are well recognized CV risks...simply read the studies on Heartwire
I was interviewed for the Reduce it trial and I can tell you they are recruiting high risk coronary artery disease patients ...those with stents , history of heart attacks etc as well as diabetics with known CAD ....they are recruiting these patients because it is these folks that will benefit the most if Vascepa works as ( as I believe it does )
Reduce it is the study of the right group of patients at the right dose .....that is very important to understand.
it is NOT a US copy of the JELIS study.......Jelis used 1.8gms of Epadel in a fairly healthy population . Reduce It is using 4gms of Vascepa in a high risk population.
Funny, you are a bloated ignorant slob.
Lowering triglycerides has not been proven to improve your health Einstein.
So far, the FDA only knows that lowering triglycerides in patients with 200-499mg just lowers triglycerides.
Not one study has proven health benefit. We NEED improved health in order for the FDA to be interested in allowing Amarin to sell Vascepa to people. Otherwise Amarin can just sell Vascepa over the counter, like PLUSEPA.
Somebody has to demonstrate health benefits associated with lowering triglycerides.
That is why REDUCE-IT is required.
I'm not saying REDUCE-IT will fail, I believe it will show positive health benefits from the use of Vascepa. Ok, I really do HOPE it will.
THE BIG problem is that REDUCE-IT results won't be available for another three years.
THIS will be a problem for ANCHOR approval.