Amarin Corp Plc (AMRN)

[CaptBeer]

$AMRN SUNDAY SCHOOL CLASS for 10/25/2020
Topic: Is the MARINE Indication relevant?

For over two decades researchers and scientists have tried to find an association between elevated serum levels of triglycerides and the risk for cardiovascular disease and major CV events (MACE). Real World Evidence, (RWE), stacked up in favor of this theory. We knew from previous trials that lowering LDL-C (the Bad Cholesterol), with statins reduced the risk of MACE by about 35%. However, even today, reducing very high levels of TG’s (>500 mg/dl), had no proven clinical benefit. In fact, until VASCEPA was approved all available therapies (LOVAZA), showed that reducing TG’s came at the price of increasing LDL-C up to 49%! Despite what the Nevada Court determined the MARINE trial was totally unexpected, (NOT OBVIOUS).

The REDUCE-IT (Outcomes), Trial proved that VASCEPA could reduce CVE’s in all TG Groups equally. It quickly became apparent that the MOA for CVE reduction was not entirely due to TG levels. This was further emphasized by the halting of the STRENGTH Trial for futility in proving CVE risk reduction despite having higher TG reductions than VASCEPA.

So, the question remains: If reducing TG’s in hyper triglyceridemic patients has no proven clinical benefit, then why do doctors still prescribe for Generic Lovaza? This is an irrelevant indication, and the FDA should discontinue it until a proven benefit appears.