hoc for a drug development program that was not designed to prospectively measure
cardiovascular risk associated with Saxagliptin. Please discuss whether these endpoints
and the post-hoc analyses permit a reliable assessment of cardiovascular safety. Please
offer suggestions for improvements to the endpoints and analyses that may be applied to
other diabetic programs that have already completed or had ongoing phase 3 programs at
the time the Final Guidance was issued. Question No. 2 is now open for discussion.
required to conduct pre-planned adjudication of cardiovascular events and to collect
all data necessary for such adjudication. However, the Saxagliptin development program
was already complete by the time the guidance was issued. For Saxagliptin, neither pre-
planned nor post-hoc adjudication occurred and full data were not available to permit
meaningful assessment of many cardiovascular events.
guess I wanted to use this opportunity to really thank the FDA because they really
worked very, very hard on this and approached it, I think, in a sort of a difficult situation
as systematically as I think you can, and were careful. They did a great job of describing
their process that they used to get there. I guess, you know, to me again I think that’s the
best you can do in this kind post-hoc situation. You know, I think they described it well.
I am sort of reassured that if I remember everything right the, you know, SMQ MACE
data seem pretty similar to the companies, what you referred to as primary MACE. I
think the fact that they came out sort of similar is reassuring to me.
The “SMQ MACE” and “Custom MACE” endpoints were defined post-
DR. KONSTAM: I mean I don’t - I don’t really have too much to say. I
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DR. BURMAN: Correct me if I am wrong, I think it was the primary - the
company’s primary MACE.