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.