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US FDA Panel Will Reckon With Need For Diabetes Drug CV Risk Assessments

 
• By Sue Sutter

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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Whether sponsors of new type 2 diabetes drugs must continue to exclude an unacceptable increase in cardiovascular (CV) risk is the lone voting question being put to the US FDA’s Endocrinologic and Metabolic Drugs Advisory Committee at an Oct. 24-25 meeting.

However, in deciding that question, FDA wants the panel be mindful of the CV and non-CV safety findings that have come out of the completed outcomes trials to date for eight drugs, as well as the relative paucity of preapproval CV data available for

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