Slowmover...
Thnx for posting this..
In summary, the FDA reviewer says..in 2008 leading up, to the ANCHOR dyslipidemia indication, ie AMR101 added to statins...The FDA-AMRN ANCHOR SPA...was
1) They run the ANCHOR 12 week trial to determine whether AMR101 (now called Vascepa) would lower non HDL-C* as an additive to statins, at 4gm dose.
2)Begin an FDA approved clinical outcomes study using AMR101 as an additive to statins..
* In 2008 lowering non-HDL-C meant lowering trigs, because all trig lowering drugs were thought to raise LDL-C..A point AMRN must emphasize.
The FDA noted there was little evidence (prospective controlled clinical trial data) that supported the idea that adding trig lowering drugs (niacin, fibrates, Lovaza, fish oil) improved CVD outcomes. The FDA referenced the ACCORD and AIM-HIGH outcomes studies (niacin and fibrates added to statins) which were then in progress to provide "important" information on the effects of reducing lipid parameters other than LDL-C, on CVD outcomes..
Both ACCORD and AIM-HIGH failed to show significant benefits..So the panel is being asked is there enough current science to OK the ANCHOR indication..(not stated, without completion of REDUCE-IT)..
ANS..JMHO...The reviewer is leaving out some crucial information..The first is the drugs in both ACCORD and AIM-HIGH actually increased the LDL-C levels over the statin placebo control, whereas AMR101 was at the very least LDL-C neutral..The FDA clearly recognises the importance of LDL-C as a risk factor (They gave Lovaza a CRL for dyslipidemia on that issue). So the two outcomes studies cited by the reviewer do not really support the notion that lowering trigs, or other lipid parameters can not improve outcomes, but merely that raising the LDL-C is not a good thing.
IMHO..Someone with real scientific acumen needs to come to bat for AMRN..JELIS has been minimized by people all the way up to AHA spokes people who completely missed the fact that less one percent of the 18,000 JELIS cohort died during the 5 year trial period. This meagre mortality rate makes it virtually impossible to prove survival benefits without having hundreds of thousands enrolled in the trial..How can you prove a drug save lives in a population where no body dies? The rest of JELIS is very impressive..the control group finished behind the treated group in every category except for one which was a tie. Also population studies support the hypothesis that increasing the EPA/AA ratio translates out to decreased risk of CVD in the population.
Finally, AMR101 is safe...The FDA formula is risk-reward..Even if the reward here turns out to be minimal or nonexistent, there is certainly is enough evidence regarding EPA's effect on chronic inflammation and insulin resistance that the type2 diabetics should have access to this drug.
":>) JL
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