Whether or how much diabetes companies will save by dropping postmarket cardiovascular outcomes trials, if FDA follows the advice of its advisory committee, could boil down to what target they are pursuing and whether they are planning for a label claim of cardiovascular benefit.
The consensus of the Oct. 25 meeting of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) was that the overall requirements for demonstrating CV safety should be lowered. Postmarket CV outcome trials (CVOTs), most panel members argued, should be required only when a premarket signal arises that warrants further characterization.
But in lieu of a postmarket CVOT, panelists wanted to see more thorough premarket safety evaluation.
FDA’s current guidance requires preapproval studies showing a therapy does not increase the risk of CV events by 80% or more. EMDAC did not specify how much additional CV risk should be ruled out in the premarket setting.
The panel also recommended switching from placebo-controlled trials to ones that use an active