Replies to post #2751 on Amarin Corp Plc (AMRN)

[Seel]

Perhaps because of important pending patent decisions?

[DrEPE]

Yes, I do......my wife iss giving me the evil eye cause I've been on the computer for awhile.....so to be breif, here is a CC:

The election of 5-year exclusivity can only be made if:

(A)(i) the single enantiomer has not been previously approved except in the approved racemic drug; and (ii) the application submitted under [§ 505(b)] for such non-racemic drug –
(it meets this)

(I) includes full reports of new clinical investigations (other than bioavailability studies) – (aa) necessary for the approval of the application under subsections (c) and (d); and (bb) conducted or sponsored by the applicant; and
it meets this

(II) does not rely on any investigations that are part of an application submitted under [§ 505(b)] for approval of the approved racemic drug; and
it meets this, thus all the studies they did

(B) the application submitted under [§ 505(b)] for such non-racemic drug is not submitted for approval of a condition of use— (i) in a therapeutic category [(as identified in the list referenced at 42 U.S.C. § 1860D-4(b)(3)(C)(ii))] in which the approved racemic drug has been approved; or (ii) for which any other enantiomer of the racemic drug has been approved.
here is the hold up!!!!and the big question...the previous label listed an indication to lower an apo-b (this was the 'unofficially release label when they 'accidently' put the website up prior to approval'...I know this because I downloaded it before they took the website down...LOL! I have to do a bit more research into this but this is the reason for the hold up, if anyone out there can help me with this, i think our answer to the NCE will be solidified... ....

In addition to these requirements, which essentially necessitate the submission of a “full” 505(b)(1) NDA, FDARA § 264 also includes two significant limitations that may offset the incentive for electing 5-year exclusivity.

First, FDA may not approve a single enantiomer of a previously approved racemate granted 5-year exclusivity for any condition of use in the therapeutic category in which the racemic drug has been approved “ntil the date that is 10 years after the date of approval of a non-racemic drug described in [proposed FDC Act § 505(t)(1)].”
when was loveza approved....and do we have another indication for use of vascepa...help???

Second, “the labeling of a non-racemic drug described in [proposed FDC Act § 505(t)(1)] and with respect to which the applicant has made the election provided for by such paragraph shall include a statement that the non-racemic drug is not approved, and has not been shown to be safe and effective, for any condition of use of the racemic drug.”
no problem here

any feedback would help me...the apo-b lowering property previously was the key....however when the anchor trial is approved....it would qualify...but I think they get another few years of exclusivity for this....I will be back on this tomorrow, maybe we can solve this puzzle...
erik

[io_io]

why the FDA ducked what seems like a straightforward decision during the 2 prior months?

Good question! My guess is that the decision is a very difficult one, and they have to make a new policy for a case like this.