Reduce -It study should be half enrolled soon.
JELIS study--recent review of data in Atherosclerosis--shows Inflammation benefits.
Jupiter study-enrolled 15000 with avg.H-C-rp of 4.3 with 70% above 3.0. Results were dramatic in 18 months. Reason: C-RP above 3.0 has been shown to cause heart attacks.
Crestor lowered C-RP by 37%.
Vascepa lowered C-Rp by 36% in Marine trials for TG greater than 500mg./dl.
Vascepa lowered C-RP by 22% in Anchor trials for TG between 200-500mg./dl.
Now Jupiter selected 15000 based on C-RP over 2.0.We don't know the C-rp for Reduce-IT,but we do know that TG is greater than 150mg./dl--higher than JELIS 18,645 enrolled with 14,981 out of it matching Reduce-It.
Reduce-It is well designed learning from JELIS,JUPITER success and Origin study failure.
Chances that Reduce-It study will reduce Coronary events similar to JELIS--but will it match Jupiter study depends on 1) C-rp avg. or median of 8000 and 2) Statin selected.
Jupiter was comparing Crestor to Placebo --not any other statin.
Kay-do you know you status of enrollement?
If you look at Jupiter study-- it is after full enrollment--then the data is considered regularly by an independent monitoring group (Not Astra Zeneca or Amarin For Reduce-IT).
Full enrollment should be completed by the end of 2013.
Then it is possible that this independent monitoring group may release data by the end of 2015 to Amarin and Amarin to FDA and all of us.
Jupiter 15000 persons had median C-rp of 4.3 with 70% over 3.0--which is considered Heart attack waiting to happen(except high C-rp caused by virus or infection).
We need to find out what is the C-rp level of enrolled persons in Reduce-It.
JELIS also did not select 18,645 persons based on high C-rp.
Dr.Sears of Zone-Diet fame told me that Amarin should have tried 6 gram/day dosage in Reduce-IT study--then they could see great results by the end of 2014.
He sent me an article from 2011 in Atherosclerosis -that showed AA/EPA dropped from 1.6 to 0.8 in JELIS study.
More researchers in Japan are relooking at JELIS study data to learn the reasons--Inflammation lowering ability of EPA in proper dosage turns out to be the reason for sharp reduction in coronary events.
Inflammation Buster with Statin or C-Rp buster .
The nice thing-- if Crestor doesn't suit some of the patients because of side effects,then Vascepa with Lipitor Generic will be the option.
Crestor is better than Lipitor on C-RP buster .
But Lipitor with Vascepa is truly C-RP reducer/buster .
The nice thing is Vascepa has very little side effects compared to Statins.
Kay,Which statin is being used for Reduce-It study?
The sNDA is drafted and almost ready to go and should be filed this month, just need to hit that "substantially underway" mark. AMRN has said that the FDA indicated more than 50% enrolled would be the milestone to allow an application for ANCHOR to be accepted. Given the fickleness of the FDA, they could come back and say 60% enrolled but I think we're good.
My understanding is the exclusivity period for the sNDA starts once it is approved so many companies wait until the last possible moment to file it so the end date of the sNDA is further out so would not be surprised if they wait until the very last week of February to file even if they already reached the milestone which I would wager they have. I would wager they are well above what's needed by now.