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Diabetes Drugs: Longer, Broader Phase II/III Trials Could Replace CV Outcomes Trials, US Panel Says

 
• By Sue Sutter

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.

FDA Advisory Committee Feature image

Pharmaceutical manufacturers may be able to do away with dedicated cardiovascular outcomes trials (CVOTs) for new type 2 diabetes drugs, but it would come at the cost of having to conduct longer and more extensive Phase II/III studies that provide reassurance about CV safety, US FDA advisory committee members said Oct. 25.

Longer premarketing trials that enroll broader patient populations and focus on a broader variety of endpoints beyond glucose control, such...

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