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PCSK9 'Groundhog Day': Amgen’s Repatha Gains FDA Panel Backing In High-Risk Groups

This article was originally published in The Pink Sheet Daily

Executive Summary

Recommendation against broad use pending results from CV outcomes trial is a near repeat of advisory committee's deliberations a day earlier on Praluent. But Amgen drug gains one competitive advantage over Sanofi/Regeneron's PCSK9 inhibitor: a unanimous endorsement for use in homozygous familial hypercholesterolemia.

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