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Dr. Roland Chen, Group Director of CV Metabolics, who will then review

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the clinical pharmacology, efficacy, and safety of Saxagliptin. He will also show how we

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tolerated with a favorable adverse event profile. In addition, given the importance of

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demonstrating CV safety, we applied the principles outlined in FDA’s recently issued

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guidance to assess the CV safety of Saxagliptin. The results of these comprehensive

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analyses indicate that there is no increased CV risk associated with Saxagliptin treatment.

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We conclude that Saxagliptin provides clinically meaningful glycemic benefits, is well

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tolerated with no evidence of an increase in CV risk, and provides a favorable benefit risk

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profile.

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Medical Affairs, will then describe our commitment to continue to assess the benefit risk

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characteristics of Saxagliptin in the post-approval setting.

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To present our results in more detail, I would like to introduce Dr. Robert

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Wolf, Vice President and Development Lead for the program, who will briefly describe

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subject of intense interest and scrutiny, Dr. Wolf will then address the issue separately

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from other aspects of the profile of Saxagliptin and will provide an overall assessment of

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the benefit risk of the program.

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is the Associate Professor of Medicine, Division of Cardiovascular Medicine at the Duke

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University Medical Center.

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We will also present safety results that show that Saxagliptin was well

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an overview of the clinical and non-clinical development program.

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Dr. Brian Daniels, Senior Vice President for Global Development and

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We are also very pleased to have with us today Dr. John Alexander, who

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

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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

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