Amarin Corp Plc (AMRN)

[ziploc_1]

My first MI was in 2010...At that time, A coronary stent was placed and I was started on 80 mgs/day of Lipitor along with antihypertensive drugs and blood thinners....In the following years I had 2 strokes and 2 MI's resulting in the placement of 3 more stents. My last stroke was approx. 10 years ago while I was on this regime. The stroke(which, in retrospect, might have prevented if I were taking Vascepa)...resulted in my retiring from an active ophthalmology practice...

I continued with my previous therapeutic regime after my last CVD and my cardiologist at the Mass General Hospital added Vascepa 4 gms/day during the last 8 years...After my INITIAL Rx for LIPITOR in 2020, my LDL fell from over 200 mgs/dcl and has remained at under 100mgs/dcl ever since....I have not had a CVD event since taking Vascepa.

I was surprised and disappointed when the FDA set a minimum level of 150 mgms/dcl LDL or more...plus either established CVD or 2 additional risk factors for CVD,as criteria for approving patient Rx for Vascepa for the CVD indication....I believe that millions of patients with LDL under 100mgs./dcl could also be spared CVD events

At the time of the FDA approval, the FDA still had concerns about side effects from Vascepa...The fact that millions of patients used Vascepa since its FDA approval...with placebo like side effects have assuaged these fears.

IMHO it is time for the FDA to consider adjusting downwards the criteria for prescribing Vascepa.