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following questions: It should be assumed that an anti-diabetic therapy with a concerning

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cardiovascular safety signal during phase 2/phase 3 development will be required to

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conduct a long-term cardiovascular trial. For those drugs or biologics without such a

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signal, should there be a requirement to conduct a long-term cardiovascular trial or to

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provide other equivalent evidence to rule out an unacceptable cardiovascular risk? Of the

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16 voting members, 14 voted yes. The transcript from this two-day meeting is shown on

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the link on the bottom of the slide where you can also read the rationale behind the votes.

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At this meeting we discussed the Cardiovascular Assessment in the Pre-approval and

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Post-approval Settings for Drugs and Biologics Developed to Treat Type 2 Diabetes. We

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heard presentations by experts in the fields of endocrinology and cardiology. Then our

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advisory panel discussed and voted on this issue. This panel was comprised of

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endocrinologists, diabetologists, cardiologists, statisticians, and drug safety experts.

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had internal deliberations considering the discussions that had taken place at that meeting

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as well as other data and subsequently published in December a final guidance entitled,

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‘Evaluating Cardiovascular Risk in New Anti-Diabetic Therapies to Treat Type 2

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Diabetes’. I would now like to spend a few minutes talking about this guidance because

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it bears directly on what we will be discussing today. For those who are not aware, a

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guidance document is basically a document that describes FDA’s current thinking on a

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particular topic and provides recommendations on that topic.

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At the end of this two-day meeting, the panel was asked to vote on the

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For a few months after the July 2008 Advisory Committee meeting, FDA

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but is dosed twice daily. There are other GLP-1 agonists, including longer acting

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formulations, under development.

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I would now like to turn to our July 2008 Advisory Committee meeting.

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