Advicor, Simcor Withdrawals Show There's A Lot Riding On CV Outcomes Studies
Surrogate markers for cardiovascular products may be going the way of AbbVie's cholesterol franchise.
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Amgen has already reported the positive topline result of its FOURIER cardiovascular outcomes trial for its PCSK9 inhibitor Repatha, but analysts from Datamonitor Healthcare and Biomedtracker lay out the reasons to check out the full results and other highlights at the upcoming American College of Cardiology meeting.
FDA’s complete response letter for the cardiovascular risk reduction claim for Zetia/Vytorin was expected, but what will this mean for sponsors of drugs with other mechanisms, like PCSK9?
The cardiology community is increasingly questioning the value of adding on a variety of lipid therapies to treatment with highly effective statins, based on accumulating evidence of the lack of value of affecting cholesterol parameters other than LDL.