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Remember when Amarin (AMRN) said, a little more than one week ago, that the Food and Drug Administration was “unlikely” to convene an advisory committee meeting to review data on an expanded use of its heart drug Vascepa?

Wrong. On Thursday, Amarin reversed course, announcing that, indeed, the FDA has scheduled a Vascepa advisory committee meeting for Nov. 14. The agency’s deadline for making an approval decision on the heart drug will also likely be extended into late December from Sept. 28, the company said.

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  • Vascepa is yet another (about to be) FDA validated scam.
    The control group was poisoned with mineral oil.
    Instead, of using unrefined fish oil as control to prove that their product is indeed effective as therapeutic drug as compared to OTC fish oil products

    • how do we know FDA changed their mind? Just because they hadn’t signalled to Amarin back when the company issued their statement doesn’t mean FDA wasn’t pondering. The use of mineral oil as control deserves some expert perspective. Millions of potential patients means due diligence is called for. Bravo to FDA doing their job.

  • So FDA grants an expedited review of an expanded label on a drug that is completely safe and has aced a 4-5 year outcomes trial the FDA approved & helped design, a trial that mirrors results of other studies yet is better far better at reducing MACE than anything in recent years, including PCSK-9 (an injectable for which it didn’t require an AdCom), gains accolades from ADA, AHA, NEJM, leading cardiologists, and for good measure, ICER, and now, instead of holding a not-needed AdCom within the window of expedited review, they notice their calendar looks crazy so lets move it out nearly 3-months. Oh yeah, and please don’t tell Wall Street for a couple days if you don’t mind. Ok, sure. Uh-huh. Nothing to see here.

  • So let’s say the RRR is 20% vs 25%. even still, that is better than anything out there. You have a drug on the market for over 5 years without issues. Meanwhile the FDA approves drugs with side effects a page long and often time worse than what they are taken for… This is what i find most bizarre. No side effects and at worst a 20% RRR in a study the FDA designed. It is very odd and stinks of corruption. Maybe the FDA can stock the panel with 9 paid shills from AZN, AMGN, REGN, and others.

  • There are also suggestions the the Adcom may be related to the FDA’s uncertainty regarding a broader label covering other conditions such as diabetes. Was there something from the American Diabetes association recently your brief comments might have missed? The mineral oil (MO) concern has been discussed many times and the conclusion was that MO could not account for the massive RRR seen given the p values shown.
    If I’m wrong here, it would be nice to know!

    • otc fish oil has no proven clinical benefit .. highly purified EPA on the other hand thanks to the Reduce it study has a stunning p-value and a 25% RRR in CVE.. death benefit of 20%. ADA has given it SOC in T2DM on top of statin users. That’s a huge endorsement out of the gate .. the adcom will be out of the endo/metabolic division… endo’s treat T2DM. The mineral oil issue was debunked a long time ago .. my thinking is this drug potentially will be prescribed to a 1/3 of US adult population .. FDA c.y.a. imo

    • as @randy stated OTC products do not have proven clinical benefits. That’s why it was the correct placebo control. But instead, Amarin decided to poison the control group with mineral oil. Of course, if they had used OTC fish oil instead, they wouldn’t have shown any significant effects for Vascepa

    • If they compared it to comparable doses of otc fish oil then the benefits would cancel out.

      Most if the studies of otc fish oil were not done at doses that would equal anywhere near 3 or 4 g per day.

      Vascepa was dosed to show an effect. They didnt do it at 1 gram for a reason. Any statement that otc fish oil has “no effect” needs to be backed up by a study showing epa doses in the range of the vascepa trial or it means no more than saying 1 mg of lipitor per day doesn’t lower cholesterol

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