Panel To Weigh Amarin’s Expanded Vascepa Use Given Clinical Outcome Concerns
This article was originally published in The Pink Sheet Daily
FDA advisors will discuss Oct. 16 whether Vascepa’s effect on reducing triglycerides is enough to overcome concerns about this surrogate endpoint not panning out in other drug’s clinical outcomes trials.
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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.
Agency makes clear that triglyceride levels are no longer an acceptable surrogate for reducing cardiovascular risk.
Decreasing cardiovascular events is the only endpoint that matters for cholesterol-lowering drugs, FDA official says at Amarin’s negative Vascepa panel, leaving little room for drug’s expanded approval based on a surrogate endpoint.