Replies to post #27240 on Amarin Corp Plc (AMRN)

[go seek]

Amarin did not ask for reduction of CVE risk on the ANCHOR indication. Steven Ketchum says same on recent conference call. That was the reason for the REDUCE-IT outcomes trial... to prove outcomes.
The FDA rescinded the SPA because based on primary outcomes of several trials involving lowering of TGs (in different drugs MOAs and different risk populations lowering TG did not meet the primary objective of the trial(s)... Reduction of CVE. But there are 6 trials, including the 3 cited by the FDA, where the sub-analyses of the High TG populations (the ANCHOR population) DID show significant CVE reduction.

[sts66]

I'm not going to go search here or the entire net for it, but you will find it if you want to convince yourself - Joe Bruno said something like "you go for the trial's purpose on the drug app/label, it's quite typical" - and it WAS normal until AMRN Adcom - the FDA stated that AMRN/ANCHOR was going to be a "test case" in public, meaning no more claims of CVE health without completed outcomes trials that prove it. The fact that they used 3 totally different drug trials with the wrong populations to back up their stance, even ones where subgroup data supported AMRN's position, went towards there "prove it first" point. Then there's the Adcom vote question - ask the panel if R-IT would succeed - that's not a question you ask if AMRN is simply asking to expand the label to TGs 200-500.