Dr. Roland Chen, Group Director of CV Metabolics, who will then review
the clinical pharmacology, efficacy, and safety of Saxagliptin. He will also show how we
tolerated with a favorable adverse event profile. In addition, given the importance of
demonstrating CV safety, we applied the principles outlined in FDA’s recently issued
guidance to assess the CV safety of Saxagliptin. The results of these comprehensive
analyses indicate that there is no increased CV risk associated with Saxagliptin treatment.
We conclude that Saxagliptin provides clinically meaningful glycemic benefits, is well
tolerated with no evidence of an increase in CV risk, and provides a favorable benefit risk
Medical Affairs, will then describe our commitment to continue to assess the benefit risk
characteristics of Saxagliptin in the post-approval setting.
To present our results in more detail, I would like to introduce Dr. Robert
Wolf, Vice President and Development Lead for the program, who will briefly describe
subject of intense interest and scrutiny, Dr. Wolf will then address the issue separately
from other aspects of the profile of Saxagliptin and will provide an overall assessment of
the benefit risk of the program.
is the Associate Professor of Medicine, Division of Cardiovascular Medicine at the Duke
University Medical Center.
We will also present safety results that show that Saxagliptin was well
an overview of the clinical and non-clinical development program.
Dr. Brian Daniels, Senior Vice President for Global Development and
We are also very pleased to have with us today Dr. John Alexander, who
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met or exceeded FDA’s exposure guidelines for new therapies of type 2 diabetes.
As cardiovascular safety of therapies for type 2 diabetes has been the