which you are hearing today, and Liraglutide, which you will hear about tomorrow. You
may notice that presentations differ slightly, and that’s because FDA picked the subset of
analysis that we feel best represents cardiovascular risk for each of the products.
analyses and you will hear more about this from our statisticians over the course of the
two days. First, FDA requested that results for these cardiovascular analyses be stratified
by study. This preserves randomization and is particularly important when there is
unequal randomization in a study. FDA also requested that an exact method be used for
at least one analysis, and you will hear from the biostatisticians the value in using these
techniques later today and tomorrow. As you can see FDA requested multiple analyses,
two treatment periods, two endpoints, multiple comparators in some cases, various
statistical methodologies. The goal of these multiple analyses was to look at the data in
different ways to assist consistency of results.
today and while they are hearing the discussions over the course of the day - The
Saxagliptin and Liraglutide new drug applications were submitted to FDA prior to
publication of the cardiovascular guidance. In fact, they were both submitted to FDA
prior to the July 2008 advisory committee meeting. These programs were not
prospectively designed for systematic measurement of cardiovascular risk.
Cardiovascular event rates were low. There were no pre-specified definitions for major
cardiovascular events of interest. For example, these programs didn’t say that for an
Importantly, FDA used the same statistical approach for Saxagliptin,
A few important considerations for the panel during their deliberations
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infarction is included is SMQ MACE but not in custom MACE. Whereas, myocardial
infarction or silent myocardial infarction are included in both.
A quick word on the statistical analysis for these cardiovascular safety