Thank you, Roland. While the cardiovascular safety profile of treatments
for type 2 diabetes has always been of interest, the regulatory environment for this topic
3 program. There was low risk for hypoglycemia. As described in the briefing book, we
observed no adverse effects with respect to lipid parameters, blood pressure, or heart rate.
Saxagliptin was associated with no or minimal differences in weight change compared
with control. In addition, we identified no hepatic, pancreatic, skeletal, myopathy, or
renal safety signals and there was no evidence for clinically meaningful or consequential
effects on laboratory parameters.
collaborated with the FDA to generate the data needed to assess the cardiovascular safety
profile for Saxagliptin. The FDA has outlined key design features for clinical
development programs to ensure adequate assessment of CV safety. The details are
discussed in the Agency’s guidance document in our briefing book. The FDAs criteria
for assessing CV safety of new therapies are summarized in the next slide.
Overall, Saxagliptin was well tolerated at all doses studied in the phase
CARDIOVASCULAR SAFETY PHARMACOVIGILENCE PLAN
ROBERT WOLF, M.D., F.A.C.C.
of treatments for type 2 diabetes would indicate that the upper band for the confidence
interval should be less than 1.8 in order for the product to be approvable. As described in
evolved prior to and after we filed the NDA for Saxagliptin.
This slide summarizes how we adapted to this changing environment and
As Dr. Joffe described, the FDA specified criterion to assess approvability
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With this, I would like to introduce Dr. Wolf, who will review the
Saxagliptin cardiovascular safety profile. Thank you.