Myers Squibb. Tomorrow we will focus exclusively on Liraglutide, a product from Novo
Nordisk. What I would like to do in the next 30 minutes or so is summarize the
objectives of this two-day advisory committee meeting, also present an overview of the
agenda for the two days. I would then like to briefly touch on the mechanism by which
Saxagliptin and Liraglutide improve glucose control in patients with diabetes.
and Gentlemen. My name is Hylton Joffe. I’m the Lead Medical Officer for the
Diabetes Drug Group at FDA. I would like to welcome everybody to this two-day
Advisory Committee meeting where we will be discussing two new treatments that have
been developed for type 2 diabetes.
meeting is to evaluate whether these two products have provided adequate evidence of
cardiovascular safety to support marketing. For this reason, we will revisit the July 2008
advisory committee meeting which discussed Cardiovascular Assessment in the Pre-
approval and Post-approval Settings for Drugs Developed for Type 2 Diabetes, and we
will also discuss our final guidance published December 2008 that talks about
cardiovascular assessment for new diabetes products. After that we will turn to the
Saxagliptin and Liraglutide new drug applications and what we will do is we will give an
overview of the cardiovascular analyses that were requested by FDA, some important
considerations for the panel to bear in mind, and then we will end with discussion points
and voting questions related to cardiovascular safety.
Today we will focus exclusively on Saxagliptin, a product from Bristol-
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.