An FDA advisory panel voted 11-4 Thursday to recommend a new type of cholesterol-lowering drug from Amgen (AMGN), but suggested limiting use to patients with a high risk of cardiovascular disease.
Sound familiar? Regeneron (REGN) got similar treatment from the same panel yesterday, with advisers voting 13 to 3 to recommend approval of the experimental drug Praluent with many panelists recommending use of the drug be limited to certain high risk patients – namely those with a genetic condition that causes high cholesterol.