and Liraglutide to assist cardiovascular safety, but it’s important that each application be
evaluated on its own merits. Today you will hear about Saxagliptin and get to vote on
Saxagliptin. Tomorrow you will hear about Liraglutide and get to vote on Liraglutide.
These development programs differed and cross program comparison should not be
conducted are post-hoc analyses based on MedDRA preferred terms. There was no
prospect of adjudication of cardiovascular events, and there was no prospect of
adjudication either. Post-hoc adjudication was not conducted because many events had
insufficient information for adjudication, getting back to this issue that these programs
were not pre-specified to measure cardiovascular risk, and therefore they were not setup
to always collect all the necessary information needed to definitively say whether event
was due to a cardiovascular event of interest or not.
asked to talk about toward the end of the day, and also the voting questions. I’m
presenting them now to provide a framework for the panel as they hear presentations over
the course of the day, so they can see the types of information FDA would like to obtain.
So, the four discussion points on this slide apply both to Liraglutide and to Saxagliptin,
which you are hearing about today. We would like the committee to discuss whether the
low cardiovascular event rates, the endpoints, and the post-hoc analyses permit a reliable
assessment of cardiovascular safety.
As I mentioned before, FDA used the uniform approach for Saxagliptin
I would now like to end with the discussion points that the panel will be
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event to be classified as a myocardial infarction it would need to meet criteria A, B, C,
The analysis you will be hearing about that FDA and the applicant