Kynamro Liver Safety Data Faces FDA Advisory Committee Gauntlet
This article was originally published in The Pink Sheet Daily
Executive Summary
Questions about liver toxicity have dogged Genzyme/Isis’ Kynamro (mipomersen), despite robust LDL-lowering. An FDA panel review in October will tell whether seemingly reassuring safety data from a long-term extension study will do the trick for U.S. approval.