The 2 PRs I have read early this morning are too sparse in detail as to what rationale the lower-level Division employed to justify it's decision.
This is the key paragraph:
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
1. AMRN submitted data attempting to show that 4 g Vascepa reduces CVE risk when taken with statins!?! WTF were they doing still trying to get REDUCE-IT label on ANCHOR!?!? Big over-reach here - management stuck to their guns and tried to go for the big enchilada instead of simply going for an ANCHOR label similar to MARINE.
2. OTOH, the bit from DMEP claims what the FDA "interpreted" what AMRN was going for in ANCHOR - the words "ostensibly and impliedly" are a projection of what someone else may be thinking - the FDA should be dealing in hard facts, not guessing what AMRN's intentions are with ANCHOR! I want to know if the FDA actually wrote that in their decision, or if that's what AMRN decided to write in their PR - it's a huge difference as to who actually wrote it.
3. Items 1 and 2 are almost at odds with each other - AMRN tried to get R-IT language on label, but then it appears they tried to get it removed, but the FDA said "uh-uh, we know what you're trying to do, no dice". Very confused over this PR.
The Thought Police: To censor and protect. Craig Bruce
