Amarin Corp Plc (AMRN)

[HDGabor]

My interpretation of ANCHOR (let’s say label):

VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with high hypertriglyceridemia (>=200 and <500 mg/dL).
Limitations of Use:
•The effect of VASCEPA on the risk for pancreatitis in patients with high hypertriglyceridemia has not been determined.
•The effect of VASCEPA on cardiovascular mortality and morbidity in patients with high hypertriglyceridemia has not been determined.
•The effect of VASCEPA as an add-on to statin therapy, in reducing the first major cardiovascular event in high-risk patient population has not been determined.

As Dr. Colman said on 16 October: “Well, good morning. On behalf of the division, I'd like to welcome all of you to today's meeting. We are here because Amarin is seeking approval of Vascepa as an adjunct to diet and in combination with a statin to reduce triglycerides and other lipid and lipoprotein parameters in adult patients with mixed dyslipidemia and coronary heart disease or coronary heart disease risk equivalent.”

However in the BD and ADCOM presentation FDA said:
“the presumption has been that improving various lipid parameters will translate into a reduction in cardiovascular risk” and “Seeking approval for: As add-on to statin therapy in subjects with mixed dyslipidemia and residually high TG levels (200 – 500 mg/dl) Cardiovascular risk reduction“
http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm371761.pdf

Also from BD: “Several cardiovascular outcome trials of non-statin lipid-modulating therapy, …, which were designed to target residual cardiovascular risk by improving lipid parameters other than LDL-C (e.g., HDL-C and/or TG) in patients optimally treated with statin therapy, failed to demonstrate unequivocally additional cardiovascular benefit from non-statin lipid-modulating drugs”

As I understood, FDA does not want to approve ANCHOR since it does not have benefit for patients, and this is the main reason to approve any drug.

a.) Based on available information – and since Amarin doing R-IT – Amarin did not apply for “cardiovascular benefit” in ANCHOR. It’s the target of FDA.
b.) The citied studies, “failed to demonstrate unequivocally additional cardiovascular benefit from non-statin lipid-modulating drugs” in patients with borderline high (ACCORD-Lipid and AIM-HIGH - TG 162 and 161 mg/dL) and normal (HPS2-THRIVE TG 125 mg/dL) TG, but not with high TG …Furthermore the sub-group data made stronger the hypothesis (not confirmed, but definitely not failed)

This is the reason why I could not imagine the offer for ANCHOR’s SPA revision which allow Amarin to market Vascepa in high TG population.
Please let me/us know what the exact offer of FDA was. (I do not need a link or source just the wording of the offer).

R-IT enrollment: 2013/09: 6,000; 2013/12: 6,500; 2014/05: 6800;
Q42013 CC: “Right now, we would project, based upon the mix that we're seeing and the timing of enrollment, that enrollment would be completed somewhere in the first half of 2015.”

BioChica: It’s true R-IT SPA was amended to TG = 200 to <500 from TG = 150 to <500 mg/dL around June-July, 2013.