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Msg  4412 of 6776  at  6/20/2019 11:24:47 AM  by


 In response to msg 4409 by  sphericalkutz
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Re: Epanova

  Thanks for the input. After reading my post again I wrote that example pretty badly - what I was trying to say is that there have been CVOTs that were criticized for not running long enough to trust the results - too many patients were enrolled in order to finish quickly and get a label update - but for the life of me I can't remember which one I'm thinking of - was a large trial of at least 18k patients that lasted ~3 yrs, may have only been 2.5 yrs.
ODYSSEY will likely be seen as both consistent with FOURIER, the earlier cardiovascular outcomes trial (CVOT) with Amgen’s evolocumab, and an incremental advance on that trial. Despite differences in patient populations and trial design, both trials resulted in a significant but modest 15% reduction in the primary endpoint. But the ODYSSEY mortality results and the subgroup results in patients with baseline LDL levels over 100 mg/dl appear to confer a decided advantage for ODYSSEY. The results will likely be seen as confirming the view that Amgen may have shot itself in the foot with FOURIER. In an attempt to gain a competitive advantage over Sanofi/Regeneron, Amgen increased the size of FOURIER to accumulate more endpoint events in as short a period of time as possible. As a result FOURIER was able to report results one year before ODYSSEY. But the downside is that FOURIER may have been unable to reflect the full benefit of evolocumab, since many events in the trial occurred before the beneficial effects of the drug had time to emerge. 

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Msg # Subject Author Recs Date Posted
4413 Re: Epanova sphericalkutz 0 6/20/2019 11:49:13 AM

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