US FDA Panel Will Reckon With Need For Diabetes Drug CV Risk Assessments
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.
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US FDA withdraws controversial 2008 guidance that required sponsors to exclude threshold levels of cardiovascular risk before and after approval; new draft guidelines emphasize duration of exposure and breadth of safety evaluations in more diverse Phase III trial population, consistent with advisory committee recommendations.
Diabetes Drug CV Outcomes Trials May Be Needed For Market Success But Not Approval, US FDA Panel Says
Longer, broader premarketing trials should replace the requirement for dedicated outcomes trials to demonstrate CV safety, but competitive pressure may drive sponsors to voluntarily conduct outcomes studies to demonstrate CV benefit, FDA advisory committee members said.
Premarketing trials that enroll more diverse patient populations and include targeted CV endpoint collection over longer periods of time could be sufficient to allow new type 2 diabetes drugs to reach market without need for a dedicated safety study, advisory committee members say, urging FDA to move away from current two-step approach to cardiovascular risk assessments.