today and one specific for Liraglutide for tomorrow. The Saxagliptin specific discussion
point asks the committee to discuss whether the trial designs affect interpretation of
cardiovascular results for the short-term period and for the combined short-term and
long-term periods. For Liraglutide tomorrow, you will hear subgroup analyses
comparing cardiovascular safety with Liraglutide to placebo and to active comparator.
Of note, the primary comparison of interest for FDA is cardiovascular safety of
Liraglutide compared to total comparator, and the guidance doesn’t talk about applying
these criteria of 1.3 or 1.8 to subgroup analyses.
improving the endpoints and analyses that we may apply to phase 3 programs that either
were completed or near completion when the cardiovascular guidance was issued. We
would also like the committee to discuss the adequacy of the statistical methods for
measuring sensitivity of the results to analytical method.
following question, which is identical for Saxagliptin and Liraglutide and it reads as
follows. Based on the preceding discussion, has the applicant provided evidence of
cardiovascular safety to conclude that Saxagliptin (today)/Liraglutide (tomorrow) rules
out unacceptable excess cardiovascular risk relative to comparators, including evidence
We would like to hear from the committee if there are suggestions for
There are two other discussion points; one specific to Saxagliptin for
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differences noted by type of comparator and the role that these separate types of
comparatives could play in the evaluation of cardiovascular risk for future diabetes drug
Nonetheless, we would like the committee to discuss the relevance of the