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alliance to develop novel therapies for the treatment of type 2 diabetes. Today we will

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present the results of our development program for Saxagliptin, a highly potent, selective

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and reversible DPP-4 inhibitor. We are seeking an indication for Saxagliptin to improve

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glycemic control in patients with type 2 diabetes, as an adjunct to diet and exercise, when

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used as monotherapy, combination therapy with Metformin, a TZD, or a Sulfonylurea,

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and as initial combination therapy with Metformin. A robust clinical development

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program was conducted where a total of 5,346 subjects were evaluated in phases 1

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through 3. Treatment with Saxagliptin resulted in consistent clinically meaningful and

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statistically significant reductions in HbA1c, fasting plasma glucose, and postprandial

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plasma glucose.

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SPONSOR PRESENTATION

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BRISTOL-MYERS SQUIBB

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INTRODUCTION

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JOSEPH LAMENDOLA, PH.D.

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Joffe. We will now proceed with the Sponsor presentations. I would like to remind

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public observers at this meeting that while the meeting is open for public observation,

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public attendees may not participate except at the specific request of the panel. I believe

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Dr. Lamendola is the first speaker.

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Mr. Chairman, Members of the Endocrine and Metabolic Drugs Advisory

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Committee and FDA, good morning. My name is Joe Lamendola and I’m Vice President

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DR. BURMAN: Thank you very much. Thank you very much, Dr.

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of Global Regulatory Sciences for Bristol-Myers Squibb.

In January of 2007 Bristol-Myers Squibb and AstraZeneca formed an

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