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asked of Liraglutide because it’s not applicable there. The second question that the panel

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would be asked to vote on today reads as follows. For the custom MACE endpoint the

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upper bound of the two-sided 95% confidence interval for the risk ratios, odds ratio was

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less that 1.3. These data involved the total of 11 cardiovascular events in the 24-week

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double blind short-term study periods and a total of 40 cardiovascular events in the

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combined short-term and long-term study periods of median 62 week exposure. Are

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these data adequate to conclude that post-marketing cardiovascular safety trials are

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unnecessary? If voting “No”, please comment on the limitations of the completed NDA

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program that will require additional post-marketing trials.

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This question is getting at two issues; one is this number of 1.8, and the

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second issue is the data that was used to generate the number that is being compared to

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prior to the diabetes cardiovascular guidance. These programs were not prospectively

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designed to measure cardiovascular risk. Nonetheless, FDA requests that these programs

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provide adequate evidence of cardiovascular safety to support marketing. Today we will

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hear the data from the applicant and FDA in this regard and we look forward to a

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thoughtful discussion from the panel. Thanks for your attention.

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In conclusion, the Saxagliptin and Liraglutide programs were completed

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that the upper bound of the two-sided 95% confidence interval for the risk ratios, odds

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ratios is less than 1.8.

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1.8. If the committee votes “No” to this question, what additional cardiovascular data are

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needed to address any limitations resulting from the completed clinical development

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program and to support approvability including satisfying the 1.8 non-inferiority margin.

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Saxagliptin is going to have a second question; this question will not be

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