Cholesterol Endpoints Draw Scrutiny At HoFH Panels

The Metabolic and Endocrinologic Advisory Committee accepts LDL lowering as endpoint for homozygous hypercholesterolemia drugs, backing approval of Aegerion’s lomitapide by 13-2 and Genzyme’s mipomersen by 9-6, but hones in on the need for better surrogates for cardiovascular morbidity and mortality.