Heart of FDA's 1st PCSK9 review: population, ditching statins
This article was originally published in Scrip
Executive Summary
FDA drug reviewers on 5 June had little safety or efficacy concerns about the first of the experimental proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitors to come before the agency as a treatment to lower low-density lipoprotein (LDL) cholesterol in certain patients.