Replies to post #10767 on Amarin Corp Plc (AMRN)

[yellow_bluff]

i would think that if the nda had been rejected, omth would have disclosed it as a material event...

[KCSVEN]

I don't see the citizens petition holding up NCE decision as you state.

1) The citizens petition was sent 6-7 months after Vascepa approval-Why the 6-7 month delay to begin with then?
2) The petition is NOT asking to have icosapent ethyl to be added to the OB or label for Lovaza
3) The petition is to change the weight description to only list the total weight of active ingredients

Currently Lovaza label is "1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS"

What they are arguing is that other drugs just list the active ingredient.
As they state in there argument
"Although the reference to
900MG — standing alone — would be consistent with that framework, the other properties FDA included in the description of the product strength are not."

They would not have even filed the petition IF the OB listed them as 900 MG of ethyl esters. The complaint is that they also weigh out the total pill so any filler or whatever is also listed in the OB which they are saying is not an accurate way to list it.

In a nutshell the argument is:(excerpt)

"Instead, the current strength listing gives undue prominence and inappropriate importance to the 1GM product weight/fill weight of the Lovaza Capsule — a parameter which is driven by excipients and other factors presumably delineated in the Lovaza NDA that are not relevant to product strength. As a result, the current strength adopted by FDA does not plainly (and singularly) identify the amount of active ingredient per capsule."

Since there is 840 mg on the label between 465 EPA and 375 DHA they are also OK with 840 mg on the label.

They do mention Vascepa as an example where a similar drug(and one they note has EPA-sames as the Vascepa as below

"One notable example is the Agency's recent approval of a related drug product, Vascepa (icosapent ethyl), whose active ingredient is the same as the more prominent of the two major omega-3-acid ethyl esters in Lovaza. For Vascepa, as reflected in the Orange Book, FDA adopted a strength of 1GM, which is the amount of active
ingredient in an administration unit as identified in the drug labeling."

However the sole purpose of the mention is to show how the labeling for Vascepa is active ingredient ONLY and for Lovaza it has active ingredient and total weight.

THEY ARE ONLY ASKING FOR A CHANGE TO THE LABEL TO LIST JUST THE ACTIVE INGREDIENT WEIGHT.

THIS HAS NOTHING TO DO WITH NCE AND VASCEPA.

Once this is decided it has zero bearing on NCE. My guess is your CDER was throwing anything out there so you'd stop bothering them and I'm sure YOU mentioned this petition and they just didn't deny it because there is nothing in that petition which would have any effect on NCE.