following questions: It should be assumed that an anti-diabetic therapy with a concerning
cardiovascular safety signal during phase 2/phase 3 development will be required to
conduct a long-term cardiovascular trial. For those drugs or biologics without such a
signal, should there be a requirement to conduct a long-term cardiovascular trial or to
provide other equivalent evidence to rule out an unacceptable cardiovascular risk? Of the
16 voting members, 14 voted yes. The transcript from this two-day meeting is shown on
the link on the bottom of the slide where you can also read the rationale behind the votes.
At this meeting we discussed the Cardiovascular Assessment in the Pre-approval and
Post-approval Settings for Drugs and Biologics Developed to Treat Type 2 Diabetes. We
heard presentations by experts in the fields of endocrinology and cardiology. Then our
advisory panel discussed and voted on this issue. This panel was comprised of
endocrinologists, diabetologists, cardiologists, statisticians, and drug safety experts.
had internal deliberations considering the discussions that had taken place at that meeting
as well as other data and subsequently published in December a final guidance entitled,
‘Evaluating Cardiovascular Risk in New Anti-Diabetic Therapies to Treat Type 2
Diabetes’. I would now like to spend a few minutes talking about this guidance because
it bears directly on what we will be discussing today. For those who are not aware, a
guidance document is basically a document that describes FDA’s current thinking on a
particular topic and provides recommendations on that topic.
At the end of this two-day meeting, the panel was asked to vote on the
For a few months after the July 2008 Advisory Committee meeting, FDA
Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com
but is dosed twice daily. There are other GLP-1 agonists, including longer acting
formulations, under development.
I would now like to turn to our July 2008 Advisory Committee meeting.