There is a new FDA draft guidance for industry available entitled “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control’’. This draft replaces two older guidance documents from 2008 with recommendations for CV risk evaluation for new T2DM drugs. In the new draft guidance, FDA’s recommendations on evaluation of safety for new drugs and biologics to improve glycemic control in T2DM patients are outlined.
In December 2008 the FDA issued a guidance for industry with recommendations on the evaluation of CV risk for new antidiabetic agents, stating that it should be demonstrated that new agents would not result in an unacceptable CV risk increase. Since 2008, no CV outcome trial (CVOT) has demonstrated increased risk for CV events. In contrast, some have shown reduce risk for CV events. Considering these CVOT results, the FDA now proposes an updated approach to evaluate the safety of new drugs and biologics to improve glycemic control. Older guidance documents from 2008 are withdrawn because their recommendations for safety assessment have become outdated.
The intention of publication of this guidance is to provide clarity on the expectations for development of drugs and biologics to improve glycemic control and serve as a focus for commentary and feedback.
The FDA is interested in comments from stakeholders with regard to issues in this draft guidance. In particular, the FDA has raised several questions on the following topics: size of population and exposure to the investigational drug/biologic, demographic characteristics of the population, necessary safety evaluations. Comments on the draft guidance should be submitted to the FDA by June 8, 2020.