Assessing CV Risk in T2DM Products: Regulatory Experiences and Examples at CDER/FDA

• Activity Number: 399
• Type: Invited
• Date/Time: Tuesday, August 11, 2015 : 2:00 PM to 3:50 PM
• Sponsor: ENAR
• Author(s): Janelle K. Charles*
• Companies: FDA

Abstract

The 2008 FDA Guidance to Industry for assessing cardiovascular risk in T2DM products recommends that sponsors of new antidiabetic products show that unacceptable increase in CV risk can be ruled out: at pre-market with a 1.8 risk threshold and at post-market with a 1.3 risk threshold. Sponsors have used various approaches that utilize data from CVOTs in assessing these CV risk thresholds; for example, use of interim data from an ongoing CVOT for assessing the 1.8 threshold and final data from the CVOT for assessing the 1.3 threshold. These approaches present numerous design, operational, and methodological issues. This presentation will discuss regulatory experiences, through a few recent case examples, and highlight some lessons learnt.