Since Oct 2013, I have re-read the follow document for more than 10 times:
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FOOD AND DRUG ADMINISTRATION (FDA)
Center for Drug Evaluation and Research (CDER)
Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC)
FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center
(Rm. 1503), Silver Spring, MD
October 16, 2013
DRAFT QUESTIONS
Page 1 of 1
1. DISCUSSION:
In ANCHOR, 12 weeks of treatment with Vascepa 4 g/day led to an estimated median -21.5% (95% CI, -26.7% to -16.2%; P<0.0001) change in fasting triglycerides, compared with the mineral oil placebo, among statin-treated patients with mixed dyslipidemia at high cardiovascular risk. Changes in other lipid/lipoprotein parameters (selected secondary and exploratory endpoints) are summarized in the table below.
Median % Change from Baseline to Week 12
Median % Change
(95% CI)
Placebo
Vascepa 4g/day
Treatment Difference
Fasting TG
+5.9
-17.5
-21.5 (-26.7, -16.2)
Direct LDL-C
+8.8
+1.5
-6.2 (-10.5, -1.7)
Non-HDL-C
+9.8
-5.0
-13.6 (-17.2, -9.9)
VLDL-C
+15.0
-12.1
-24.4 (-31.9, -17.0)
Apo B
+7.1
-2.2
-9.3 (-12.3, -6.1)
Tot. Chol.
+9.1
-3.2
-12.0 (-14.9, -9.2)
HDL-C
+4.8
-1.0
-4.5 (-7.4, -1.8)
Apo A-I
+3.6
-2.9
-6.9 (-8.9, -4.9)
Please discuss the efficacy results from the ANCHOR trial, including the clinical significance of the observed changes in lipid/lipoprotein parameters and your level of confidence that these changes will translate into a meaningful reduction in cardiovascular risk among the target population.
2. VOTE:
Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT? Please provide the rationale underlying your recommendation.
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I think FDA did a very right decision. Now, I am waiting FDA to do another very right decision: Approve REDUCE-IT sNDA ASAP followed its submission (in coming March). And I believe FDA will -- it's about saving lives. I expect the approval will come out in July or August.
Talking about Vascepa's commercialization, GIA is a very slow approach for tiny Amarin. I am looking for a partnership or a buyout. I prefer a BO more than a partnership, because I am just an individual investor (my investment is concentrated on AMRN), a lumpsum is perfect to me. 5+ years is a long way, but not a length of time can measure success. It is your homework and your confidence on your homework. I am so glad we longs get award.
