*************From IHUB*********************
IMO, the FDA always wanted to have an ADCOM about this. You can tell this from the 2013 ADCOM slides which I will point out below. However, reduce-IT was so profound and unexpected, they thought one wasn’t needed. From the 2013 ADCOM slides:
“Treatment with 12 weeks of VASCEPA 4g/day vs. mineral oil placebo demonstrated statistically significant improvement in TG and other lipids/lipoproteins in statin-treated patients
• Recent cardiovascular outcome trials with fenofibrate and niacin call into question whether targeting lipids/lipoproteins other than LDL-C yield incremental CV benefit in the setting of contemporary statin therapy
• Cardiovascular outcome trials with Omega-3 Fatty Acids do not consistently support benefit
• Thus, whether the lipid changes, specifically TG (and non-HDL-C), observed in the ANCHOR study will translate into lower rates of major adverse cardiovascular events is **debatable**
• REDUCE-IT – will assess whether treatment with VASCEPA improves clinical outcomes among statin-treated patients with residually elevated TG”
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They had serious doubts as to whether lowering lipids or other biomarkers that were not LDL-C had any CV benefit, namely because other trials were failing to show this (these other trials were also the primary reason for the rescindment of the SPA). Lowering LDL-C was the gold standard for decades and Vascepa would have been the first class of drugs, that didn’t target LDL-C, indicated for CV benefit in patients with residual risk after statin therapy. This is why they waited for reduce-it. Because it was too big of a deal to approve without a CVOT (though they should have known this earlier).
Well guess what. Reduce-IT was a game changer. Whatever doubts the FDA had at the 2013 ADCOM were ANSWERED.
But, you have to understand, this is still PRACTICE CHANGING. Vascepa is still the first kind of it’s class in this indication (possible huge indication) and the FDA, probably after being pressured by the recent scandal, finally decided to convene an ADCOM.
Everything will be discussed. MO, hsCRP, possible MOA’s, possible EVAPORATE data. Everything needs to be put to bed because this will change the dynamics of CVD prevention for decades.
It will be an easy approval:
1. Never in the history of the FDA have they rejected a drug that was ALREADY a standard of care by a major association.
The ADA gave it a grade A level, meaning: “it reflects that REDUCE-IT was considered to be a large well-designed clinical trial. Generally, according to ADA, A-level recommendations have the best chance of improving outcomes when applied to the population to which they are appropriate.
The ADA already answered the MO, and hs-CRP issue for the FDA by giving Vascepa this grade. It is a NON ISSUE (but will be discussed).
The AHA will also give its blessings later in the year, most likely at the scientific sessions in November, per an email I received that I shared a while back and the titles of the presentations that are more than telling such as: “ Omega-3 Fatty Acids, EPA and CVD Risk: No Longer a Fish Tale?”
Program Planner
2. The ICER report gave it a B+ rating. This rating is confusing. It is also separate from it’s cost-effective rating.
It would have been impossible for Vascepa to get an A rating because it’s indication is so vast, there will be people who take it who will only receive a small net benefit (people who might not need it, but fall right at the borderline of the cohorts). B+ includes ALL people who can gain a small net benefit to a SUBSTANTIAL net benefit.
You might find an A rating on a drug for a disease that is so devastating that EVERYONE who takes it will have a substantial net benefit (sickle cell disease, cancer, etc). See the graphical representation of this here on page 3:
http://icer-review.org/wp-content/uploads/2016/02/Rating-Matrix-User-Guide-UPDATED-06.30.17.pdf
The cost benefit analysis indicated an $18k/ QALY gained. I’ve done extensive research, and cannot find another drug that comes close to these numbers. Not even statins (non-generic) beat Vascepa in this regard (from meta studies:
Statin cost effectiveness in primary prevention: A systematic review of the recent cost-effectiveness literature in the United States)
Amarin could double the price of Vascepa and it would still be cost effective. If anyone can find a drug that has a better number than 18k/ QALY please let me know. If you think Vascepa can do 10B in annual sales, BP could easily make that 15-20B by increasing it’s price (and trust me they know this already).
3. Deepak Bhatt is a HIGHLY regarded cardiologist. His reputation is on the line and I have no doubt will be presenting for Amarin at the ADCOM. He has stated many times Vascepa will be practice changing. He is followed on Twitter and will be presenting with multiple people at the AHA that are on the Advisory Committee.
4. Let’s talk about MRC for a second. Or whoever you want to call him (pyrr etc). Why go through such great lengths to hide your identity if you want to be taken seriously as a research entity? Why did he or “they” come out of nowhere and focus so vehemently on ONE company?
Occam’s Razor. He wants the price to go down because he or his client will profit from it. Simple as that. Pure manipulation and fear mongering so that money can be made.
He was right about the ADCOM, but his reasoning for it is WRONG. However, he did his job. He instilled fear and a lot of retailers sold their positions because maybe they thought he could be right.
Don’t listen to this fool. This is the fool who was taken to school by Ortakoy here:
Amarin Corp. PLC ADS AMRN Post # 208354 and proven to be a clown by being wrong about reduce-it in September.
Remember all that talk he spewed about ethyl esters not being bio-available? The post hoc analysis of the Anchor trial proves him DEAD WRONG. Plasma EPA went from 29 to 179 and RBC EPA went from 11 - 67... in TWELVE WEEKS.
But this is his job. To spread bullsh*t facts in an articulate manner so that retailers will sell. Are we really to believe that he knows more and is smarter than Deepak Bhatt? The ADA? The AHA/ACC? Multi-billion dollar hedge funds? And countless other doctors that have endorsed reduce-it? Or is it more reasonable that MRC, who takes immense measures to hide his identity and spread fear regarding ONE company under the guise of a “research entity” is here simply to make money by trying to crash the SP of AMRN. I guess it’s for you to decide.
My guess? Institutions/hedge funds want in cheap. They might think a BO is imminent. They can make money on both sides of the trade (short, then accumulate).
Note that % ownership has constantly gone up since reduce it read out, yet we are still below 50% owned. Look at ARRY, ONCE, AGN, RHT, and any other BO of a company. Institution ownership of those stocks are almost ALWAYS over 80% before BO
