TCI1,
Amarin will want LR-EtEPA approved not only for triglyceride lowering in severe hypertriglyceridemia (≥500 mg/dL), but also for the cardiovascular risk reduction indication (the real value driver).
The FDA might be cautious about automatically granting the CV indication without some evidence that the new formulation replicates the REDUCE-IT benefits. While it’s biologically reasonable that EPA is EPA, the FDA will want to see that the new formulation is safe and that any differences do not adversely affect efficacy.
Amarin will likely pursue a 505(b)(2) New Drug Application (NDA) for LR-EtEPA, referencing Vascepa’s extensive safety and efficacy data.
Amarin could submit pharmacokinetic bridging studies and clinical data demonstrating that, for example, 2 g of LR-EtEPA has similar effects to 4 g of Vascepa on triglycerides and inflammatory markers.
It can perhaps undertake a smaller study in cardiovascular patients to compare EPA blood levels on LR-EtEPA vs. Vascepa.
Given that MND-2119 is already approved in Japan as of 2023 for hyperlipidemia, Amarin can leverage Japanese data in their FDA submission. This includes Mochida’s 52-week study confirming TG-lowering efficacy in patients with high triglycerides.
Finally, the FDA could require post-marketing studies. One potential requirement could be an outcomes registry where patients switched to LR-EtEPA are followed for CV event rates, to ensure consistency with prior data. Such a study could be done post-approval.
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