Amarin Corp Plc (AMRN)

[HDGabor]

I do not want to bickering - - with you, just present other view:

Facts:

1.) To approve any drug as a combination with statin in TG =>200 mg/dL and =<500 mg/dL population is for CV risk reduction

“I could think of to lower triglycerides or raise HDL or change LDL composition, Apo B levels, particle size -- the only reason to want to do that is to prevent cardiovascular events” (Dr. Hiatt / AdCom)

2.) AdCom was not ANCHOR’s AdCom since “the issue on the table today is whether we should approve something as a surrogate endpoint.” (Dr. Hiatt / AdCom). It's - at least - more than unfair, unacceptable to discuss this during the AdCom of SPA supported drug, 2 months before PDUFA date.

3.) Vascepa label with or without ANCHOR includes and will includes (till R-IT approval):

Limitations of Use:
- The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
- The effect of VASCEPA on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.

4.) This part of the proposed indication could not be questionable (also on Niaspan’s and Tripilix’s label):

„as an adjunct to diet and in combination with a statin to reduce TG, non-HDL-C, Apo-B, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia”

Question / Discussion:

„as an adjunct to diet and in combination with a statin to reduce TG, non-HDL-C, Apo-B, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent.

CHD risk equivalents comprise:
o Other clinical forms of atherosclerotic disease (peripheral arterial disease,
abdominal aortic aneurysm, and symptomatic carotid artery disease);
o Diabetes;
o Multiple risk factors that confer a 10-year risk for CHD > 20%”

My view:
- it’s not indicate CV reduction, it’s the target population and as I remember JB said it was worded based on existing, FDA approved label
- Trilipix’s label includes exactly the same wording: (1.1 - Trilipix label) and Trilipix is still approved – after ACCORD-Lipid and Trilipix’s AdCom (see Vascepa FDA BD page 81)