JL, still long this stock, just don't post anymore but the idea that Amarin tried to sneak in expanded labeling is just a farce. Here are the excerpts out of the adcom briefing doc:
FDA Briefing Document
Endocrinologic and Metabolic Drugs Advisory Committee Meeting
October 16, 2013
The applicant now seeks the following indication:
? Co-administration Therapy with Statins for the Treatment of Mixed Dyslipidemia VASCEPA® (icosapent ethyl) is indicated 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.
8. BENEFIT/RISK EVALUATION IN CONTEXT OF CURRENT SCIENTIFIC KNOWLEDGE
The indication sought for VASCEPA 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 is based on the lipid changes observed in the ANCHOR trial. With rare exception, FDA has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes. The experience with statin therapy, where effects on the lipid profile (primarily LDL-C) consistently later translated into proven cardiovascular risk reduction, seems to provide a supportive example. However, as demonstrated in large trials of patients with congestive heart failure or end-stage renal disease on dialysis, even lowering LDL-C with statins does not always appear to decrease cardiovascular risk. More relevant to the current proposed indication, other non-LDL-C lipid surrogates (e.g., TG) have not uniformly conformed to the paradigm that improving lipid values reduces the risk of cardiovascular events, especially among contemporary patients treated with statins. Therefore, in considering the benefits of AMR101 treatment and the implications of granting approval for co-administration with statins, EMDAC members should consider the clinical significance of the observed lipid changes in ANCHOR in the context of the available scientific knowledge, such as clinical trials and meta-analyses that have evaluated the cardiovascular benefit observed with omega-3 FA consumption as well as recent large cardiovascular outcome trials that have failed to demonstrate a reduction in residual cardiovascular risk with non-statin lipid-altering treatment, despite improving parameters such as HDL-C and/or TG, in patients optimally treated with statin therapy.
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