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Diabetes Outcomes Trial Requirement Looks 'Increasingly Wise' – FDA’s Temple

 
• By Michael McCaughan

FDA’s review of novel efficacy endpoints for diabetes therapies inevitably included discussion of the future of the cardiovascular outcomes study requirement for type 2 diabetes therapies; comments by FDA and EMA officials sure make it sound like the requirement isn’t going away any time soon.

The requirement for antidiabetic drug developers to conduct cardiovascular outcomes studies is unlikely to be eliminated any time soon, based on comments by regulators from FDA and the European Medicines Agency during an Aug. 29 FDA workshop on new diabetes endpoints.

While the focus of the meeting was on new efficacy endpoints – in the words of the agenda, “beyond” hemoglobin A1c levels – the 2008 FDA requirement for all sponsors of type 2 diabetes drugs to rule out an excess risk of cardiovascular adverse events was an inevitable topic of discussion

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