Replies to post #163295 on Amarin Corp Plc (AMRN)

[BioChica]

Yes I mentioned weight loss as a potential new indication around a year or two ago. They would have solid patient records for weight in this trial. If it is possible to do this, I would think so in such a large trial - it would be definitive proof compared to the control arm.

[north40000]

I agree—weight loss effect in diabetics is a logical indication predicated on my own experience as a T1-D for past 5.5 years of off- label Vascepa dosage. My own weight loss of 27 lbs to present 160 lbs took some time, occurring mostly in the past year or two that is correlated with both continued Vascepa use and continued reduction of insulin dosage from that used for 60 years.

Any weight loss in Type 2 diabetics should be already- collected data points from patients in arms of R-I. trial. I recall no mention of that weight loss potential indication in PRs or presentations by Amarin or P.I.s so far.

Recall that there were too few Type-1 diabetics in Reduce-It trial from which to draw meaningful conclusions, per Dr. Busch(Albany Medical endo) comments in Q&A, evening of 11/10/2018.

[couldbebetter]

The quote makes it sound as if AMRN can use R-I info to seek FDA
approval for additional indications...I wonder what AMRN means
when they say they are "developing" Vascepa for FDA approval of
additional indications based on R-I. Would that mean an additional
trial? What exactly does the term developing mean in this particular
context? Anyone???

[sts66]

"We are also developing Vascepa for FDA approval of additional indications based on Reduce-It."

Keep it simple folks - that says AMRN is seeking a new indication for V, and in this case means getting R-IT on the label, nothing more. The plural might be related to certain subgroups or SEs that could also make the label. Think about it for a second - tertiary endpoints and other observations cannot go on the new R-IT label by definition, so weight loss and other stuff being mentioned here is not in the cards even if the V group lost a decent amount of weight.

[sts66]

"We are also developing Vascepa for FDA approval of additional indications based on Reduce-It."

Keep it simple folks - that says AMRN is seeking a new indication for V, and in this case means getting R-IT on the label, nothing more. The plural might be related to certain subgroups or SEs that could also make the label. Think about it for a second - tertiary endpoints and other observations cannot go on the new R-IT label by definition, so weight loss and other stuff being mentioned here is not in the cards even if the V group lost a decent amount of weight.