jdhartin - You hit that one the head! I've been saying that since they shot them down October 16th... When I heard the FDA focus on CVE's, I called Joe Bruno at Amarin and asked the very same question you asked (Why Not Just get an Approval on the 199 to 500 Trig Class without the CVE language):
His reply was: "That was our intention."
I asked why the Anchor application mentioned CVE's when Anchor was ONLY an extension of Marine (which has an exception to CVE's and is one of the reasons why the FDA approved them the 1st time!)
He said you normally list the ultimate intent in your application when you file a sNDA.
Had Amarin ONLY asked for an extension of Vascepa for the 199 to 500 class with the application noting that the Anchor label will carry the very same exceptions as Marine, we probably would not be talking about this now...
Here is the argument with that position:
As the FDA stated on October 16th:
Vascepa's Marine treats people with Inflammation of the Pancreas which is helped by reducing Very High Trigs.
YET THE FDA MADE THEM PUT ON THE LABEL THAT VASCEPA HAS NOT BEEN TESTED OR PROVEN TO REDUCE INFLAMMATION OF THE PANCREAS!
So right now Vascepa has no proven benefit yet the FDA approved them!?!?!?!?!
So now that the FDA is changing their position on Drug Approvals wanting a definite proven successful endpoint (meaning what does this drug help or cure), we risk having Marine pulled if we use a Reduction of Trigs as the primary and only proven benefit of Vascepa - if it has not proven to benefit anything!?!?!?!?!)...
After-all, it has not been proven to reduce the effects of Inflammation so what does it do?
We either have to get the FDA to agree that a reduction of High Trigs (200 to 499) is effective for something without a proven endpoint or we have to wait for Reduce-It to prove a benefit.
It does not appear that the FDA is going to break their new rules!
So do we fight and fight and fight and possibly lose Marine since it really has "no proven benefit" in the FDA's eyes (see the label)?
We ALL want them to approve Vascepa in the meantime "knowing" it is safe and effective in bettering Lipid Panel Results.
I have been saying all along that Vascepa (I hope) will be approved for the 199 to 500 Class with the very same Language as Marine just as you suggested YET that may have worked before the "new and improved" FDA dug their feet in and allowed drugs go to market that are proven to be safe and effective.
They are questioning the Safety by discussing Internal Bleeding concerns, and they are questioning Effective because it has not been proven to do anything positive for people (in their minds)...
WE (and the FDA) all know it betters Lipid Panel results!
Yet that is not a "primary proven endpoint" (in their eyes) yet it should be...
This bring them back to: It does not Reduce CVE's!
SOOOOO - OK already... We agree! Approve Anchor with the very same exceptions as Marine on the label and lets move on!
NOTE: AMARIN IS SAYING THAT THEY ARE REQUESTING THIS FROM THE FDA.
I am HOPING that they approve it for just the (only) reason you noted: Reducing Trigs in the 199 to 500 class.
Anchor will not be approved as written with the CVE language...
I was hoping Amarin would ignore and accept the SPA rejection and move right into the Approval of Anchor with the Exceptions on the Label yet that is now on hold as Amarin wants to fight the rejection of the SPA...
The FDA agreed to treat the SPA and Anchor as completely separate actions. One down that at this point does NOT matter as long as the FDA allows Anchor soooo why not move on to a modified Anchor approval!?!
We are hoping it will be approved for a modified version of Anchor (as noted above) yet some of us want it all! The SPA and Anchor approved 100% as submitted!
NOTE: There are MANY people that want the old FDA back yet it does not appear that will happen. Vascepa is NOT the only company the FDA is pushing down this (new) road!
