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New Clinical Investigation Exclusivity (three-year exclusivity) applies when an NDA or supplemental NDA includes new clinical investigations essential to the approval [27]

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Clinical trials have demonstrated that it can reduce the risk of major adverse cardiovascular events in people with type 2 diabetes

This, in turn, compromises efficacy and limits long-term adherence

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This was first suggested for the GLP-1R agonists exendin-4 and liraglutide when it was shown that the suppression of food intake that they cause upon systemic administration is prevented or attenuated when the GLP-1R antagonist exendin-9 is centrally administered in rats [7] and when central GLP-1Rs are deleted in mice [8]