Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Because you can't take a study with a sample size of 8,000, analyze less than half, and say your analysis was adequately powered because the original population was 8,000. That's not how good science is done.
Based on our last post, would it be safe to assume you have some research background? If so, doesn't this kind of post hoc data mining raise your eyebrows just a little? The timing of this paper further increases my suspicion that subgroup data will be discussed during the AdCom. Maybe I'm completely wrong, but I was under the impression that subgroup analyses like this should be avoided because results are so underpowered that some differences could be explained by chance.
That's reasonable. The text in bold is indeed what I am predicting to be the question that's presented to the committee.
I did not use it as a 1:1 comparison. I wanted to illustrate that clinical context is also important, as discussed in the committee's rationale, not just numbers.
I don't. I am only predicting they do based on 1) that's how the populations were divided in REDUCE-IT and 2) FDA regulations require indicated populations to be specified in the label. See my example here (hyperlink).
P.S. see my previous posts because I think they address some of the things we talked about yesterday. Especially this one (hyperlink).
And I'm saying when a drug is endorsed does not matter. A drug can still be prescribed off label. See ADA on ezetimibe. It is still in the current (2019) guidelines for cardiovascular disease even though it does not have a label for it:
In other words, doctors can prescribe vascepa for primary prevention of cardiovascular disease off-label because it is within guidelines. Amarin, however, wants the label.
I am predicting the AdCom is to address the population in blue, which had a 12% RRR in cardiovascular outcomes. That does not mean they can't get the label in red, which had a 27% RRR in cardiovascular outcomes. I am just saying that the FDA is deferring to a panel of experts on whether to include BOTH populations on the label. Does that make sense?
I do realize that. As VuBru pointed out, REDUCE-IT has two populations. I am predicting the AdCom is only focused on one of them, which could go badly based on history. Overall, I still think there is the potential for a label with the second population.
Or... A very SIMILAR advisory committee for a very SIMILAR sNDA for a very SIMILAR indication based on a very SIMILAR trial resulted in a negative vote because a very SIMILAR panel of experts "were not convinced that the magnitude of the benefit seen was CLINICALLY meaningful." (emphasis is mine)
Again, please take the time to read my previous post and the included references.
I currently predict that the vote could go either way.
My prediction recently decreased because REDUCE-IT is weak regarding benefits in subpopulations, and yet, it has been brought up twice in just the last week: in the 10-Q (hyperlink) and Grand Rounds (hyperlink). This makes me suspicious that the sNDA includes language for primary prevention, in which case it might go badly for Amarin if the voting question revolves around approving Vascepa for a population that showed only a modest benefit.
Kiwi's example of ezetimibe is an excellent model of how Amarin's AdCom could go due to some eerie similarities (underlined text are hyperlinks):
Icosapent ethyl (Vascepa) Approved label: Dyslipidemia Cardiovascular outcome trial: REDUCE-IT RRR of cardiovascular outcomes: 12% sNDA for cardiovascular outcomes: 2019 Advisory committee: November 2019 Question: "Do the efficacy and safety data from the REDUCE-IT trial provide substantial evidence to support approval of a claim that adding icosapent ethyl to statin therapy reduces the risk of cardiovascular events in patients with diabetes mellitus and at least one additional risk factor?" (PROPOSED) Vote: TBD Rationale: TBD CRL: TBD
Do you have a source for that definition? Here is the exact quote from the REDUCE-IT paper (hyperlink) regarding primary and secondary prevention cohorts,
This definition was also used in the most recent 10-Q (hyperlink),
This language is also used on the Vascepa website (hyperlink),
Is it possible you're confusing "primary prevention" with "first events" as shown on slide 12 (hyperlink) and described here (hyperlink),
In regards to ezetimibe, I was responding to this comment (hyperlink),
Ezetimibe does have a relative risk reduction (RRR) in cardiovascular outcomes that is less than Vascepa (6% in IMPROVE-IT vs 12% in REDUCE-IT), however, Ezetimibe is approved for dyslipidemia (hyperlink), not cardiovascular outcomes. Like Ezetemibe, Vascepa is approved for dyslipidemia (hyperlink), however, Amarin wants to expand the label to cover cardiovascular outcomes based on REDUCE-IT results. Therefore, I am indeed suggesting that the FDA is convening an AdCom because they do not think a 12% relative risk reduction in cardiovascular outcomes is sufficient for expanding the label to include the primary prevention cohort (i.e., patients had diabetes mellitus and at least one additional risk factor).
We won't know for sure what the AdCom is about until the briefing docs are public, but the 10-Q suggested differences between subpopulations as a potential topic and then Dr. Bhatt mentioned looking more closely at prevention cohorts during last week's grand rounds. It's all very strange considering they didn't even bother to mention it in the REDUCE-IT paper (outside of figure 2).
I agree, which is why I think the FDA left it to the experts to decide whether the modest benefit is acceptable to expand the label for primary prevention.
Ezetimibe does not have cardiovascular outcomes on their label. If doctors want to prescribe it for primary prevention, they can do it off label. Doctors could do the same with Vascepa, however, Amarin wants the backing of an approved label instead.