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

10

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

12

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.

3

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

4

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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1

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

2

ratios is less than 1.8.

5

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

6

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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8

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