FDA to obesity panel: assume preapproval CV trial required

FDA instructed the Endocrinologic and Metabolic Drugs Advisory Committee to assume that sponsors of obesity products with a cardiovascular signal will be required to conduct a preapproval CV outcomes trial to rule out a "certain degree of excess CV risk." The comments came in briefing documents released ahead of the committee's meeting on Wednesday and Thursday to discuss the role of CV assessment for obesity products.

The agency will ask the committee to discuss the design of a CV outcomes trial, including whether to use a primary endpoint of major adverse cardiac events (MACE) or MACE plus hospitalized unstable angina and emergent coronary revascularization. FDA will ask the panel to vote on one question: whether products without a theoretic CV risk or signal should be required to rule out a certain degree of excess CV risk with a CV outcomes trial or an appropriately sized meta-analysis of Phase II and III MACE data. ...