"That was all FDA wanted, saving face and revising the SPA. It would have allowed AMRN to basically still market Vascepa for Mixed Dyslipidemia, with the tacit agreement to acknowledge, that there was no data as yet to prove that lowering Trgs improved Patient Outcomes, and make the SPA contingent on Reduce-IT RESULTS."
I am confused, please help me to understand.
FDA want to allow ANCHOR (for me the description is equal w ANCHOR), but Amarin refused it and would like to get REDUCE-IT under ANCHOR SPA?
I could not remember that Amarin would like to get a wording on label "lowering Trgs improved Patient Outcomes" (or not to show on label that there was no data as yet to prove that lowering Trgs improved Patient Outcomes)
As I see the situation is "opposite": FDA stated that there was data to prove that lowering Trgs NOT improved Patient Outcomes"
(btw: the first sentence is so interesting based on the FDA's new "science":
"In its communication to Amarin, DMEP stated that information submitted by Amarin supports testing the hypothesis that Vascepa® (icosapent ethyl) 4 grams/day versus placebo reduces major adverse cardiovascular events in statin-treated subjects with residually high triglyceride levels, as is being studied in the Vascepa REDUCE-IT cardiovascular outcomes study. However, DMEP reiterated its position expressed at the October 2013 Vascepa advisory committee meeting that currently available data from studies of other therapies do not support use of drug-induced reductions in serum triglycerides as a basis for approval of an indication that DMEP views as ostensibly and impliedly an indication to reduce the risk of cardiovascular disease."
FDA approach is true, but for normal or border-high TG and not for high TG.
I do not believe in the corruption theory (maybe on some level yes, in this case, but I do not see the reason for that), maybe it's a simple ego issue currently (but not for the reason you mentioned).
My science is:
1.) TG higher than 200 (150) should be treated (basically recommended by all org)
2.) no data as yet to prove that lowering Trgs improved Patient Outcomes, since study was not completed to confirm the hypothesis
3.) no data as yet to prove that lowering Trgs NOT improved Patient Outcomes, and sub-groups analysis of studies suggest the opposite (btw: when will be available the HPS2-THRIVE' subgroup data / analysis - I remember for 12 March but I could not find it)
4.) Vascepa reduces TG and safe
So, I do not say that there is 100% correlation between TG and Outcomes (since R-IT is still ongoing), however the current science, sub-groups of studies and all other info are supporting this approach.
Based on Dr. Hiatt's word at ADCOM: Lack of evidence is not null the theory and definitely not confirm the opposite.
I did not expect that DMEP reinstate the SPA, however there is a chance that higher level will (not the current ODE II).
