US FDA May Change Requirements For CV Outcomes Trials For Type 2 Diabetes Drugs
Endocrinologic and Metabolic Drugs Advisory Committee will reconsider 2008 guidance on evaluating CV risks in antidiabetic therapies at two-day meeting in October.
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Cardiovascular and non-CV safety findings from completed outcomes trials to date for eight drugs, as well as the relative paucity of preapproval CV data available for anti-diabetic agents prior to a December 2008 guidance that mandated dedicated risk assessments, may inform advisory committee's view on continuing need for large safety trials.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
US FDA apparently agreed with some of its advisory committee members that liraglutide should be approved for cardiovascular risk reduction only in diabetic patients with established CV disease, not just those with CV risk factors. GLP-1 agonist's labeling is silent on discordant efficacy results in the US patient subgroup in the LEADER trial.