Cholesterol Drug Approvals May Hinge On Outcomes Studies; FDA Rejects Diabetes-style Tiered Trials

FDA’s Deputy Director of the Division of Metabolism and Endocrinology Eric Colman indicated the agency has little willingness to accept a surrogate for new cholesterol-lowering drugs, because the products have one primary purpose – decreasing cardiovascular risk – which appears to lack another marker.

Endocrinologic and Metabolic Drugs Advisory Committee member William Hiatt asked FDA during an Oct. 16 meeting whether it would be willing to take a “staged approach” as it has with diabetes drugs, when considering whether to approve Amarin Corp. PLC’s Vascepa (icosapent ethyl) for an expanded indication in patients with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent