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Praluent, Repatha Spur Rethinking On LDL-Cholesterol As A Surrogate Endpoint

Executive Summary

FDA advisors reviewing the PCSK9 inhibitors say reliability of LDL-cholesterol-lowering to predict clinical benefit depends on patient population; they backed the Sanofi/Regeneron and Amgen drugs for patients with genetic cholesterol disorders and very high CV risk, but said approval for lower-risk populations should await outcomes data.

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