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Myers Squibb. Tomorrow we will focus exclusively on Liraglutide, a product from Novo

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Nordisk. What I would like to do in the next 30 minutes or so is summarize the

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objectives of this two-day advisory committee meeting, also present an overview of the

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agenda for the two days. I would then like to briefly touch on the mechanism by which

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Saxagliptin and Liraglutide improve glucose control in patients with diabetes.

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and Gentlemen. My name is Hylton Joffe. I’m the Lead Medical Officer for the

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Diabetes Drug Group at FDA. I would like to welcome everybody to this two-day

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Advisory Committee meeting where we will be discussing two new treatments that have

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been developed for type 2 diabetes.

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meeting is to evaluate whether these two products have provided adequate evidence of

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cardiovascular safety to support marketing. For this reason, we will revisit the July 2008

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advisory committee meeting which discussed Cardiovascular Assessment in the Pre-

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approval and Post-approval Settings for Drugs Developed for Type 2 Diabetes, and we

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will also discuss our final guidance published December 2008 that talks about

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cardiovascular assessment for new diabetes products. After that we will turn to the

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Saxagliptin and Liraglutide new drug applications and what we will do is we will give an

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overview of the cardiovascular analyses that were requested by FDA, some important

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considerations for the panel to bear in mind, and then we will end with discussion points

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and voting questions related to cardiovascular safety.

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Today we will focus exclusively on Saxagliptin, a product from Bristol-

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As you will soon see, the main focus of this two-day advisory committee

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Good morning, Dr. Burman, Members of the Advisory Committee, Ladies

INTRODUCTION AND BACKGROUND

HYLTON JOFFE, M.D., M.M.SC.

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