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US advisers endorse PCSK9 Praluent, but limited population

This article was originally published in Scrip

Executive Summary

Not wanting to withhold a new type of cholesterol-lowering drug for two years from desperate patients while waiting for cardiovascular outcomes trial (CVOT) data, a panel of experts on 9 June supported Sanofi and Regeneron Pharmaceuticals putting their proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor Praluent (alirocumab) on the US market, despite fears that an FDA approval could mean the large study testing the medicine's ability to prevent heart attacks may be abandoned.

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