FDA updates guidance for type 2 diabetes meds

The US Food and Drug Administration on Monday issued a new draft guidance, “ Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” to solicit public comment on its proposals for broad safety evaluations before drug approval that look beyond ischemic (reduced blood flow) cardiovascular disease, as well as for the inclusion of a broader scope of human subjects, such as older subjects and those with chronic kidney disease who may be more vulnerable to drug-related side effects.

The new draft guidance does not contain the recommendation that sponsors of all new therapies for type 2 diabetes uniformly rule out a specific degree of risk for ischemic cardiovascular adverse outcomes, which was recommended in previous guidance and has typically been done through cardiovascular outcome trials.

“The FDA continues to review new clinical trial evidence and update its recommendations for drug development to reflect emerging scientific information,” said Dr Lisa Yanoff, acting director of the Division for Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.