FDA Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes Medications | FDA

FDA Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes Medications | FDA

FDA Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes Medications

New Draft Guidance Considers Broader Evaluations Beyond Cardiovascular Outcomes Trials

The U.S. Food and Drug Administration today issued a new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” to solicit public comment on its proposals for broad safety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 The new draft guidance does not contain the recommendation that sponsors of all new therapies for type 2 diabetes uniformly rule out a specific degree of risk for ischemic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 Lisa Yanoff, M.D., acting director of the Division for Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “By following previous FDA recommendations, sponsors have shown that new type 2 diabetes drugs do not have excess ischemic cardiovascular risk, which has provided reassuring cardiovascular safety information for millions of diabetes patients. Now, with this proposed approach, we will have broader, valuable safety information for these medications.”   The 2020 draft guidance stems from the ongoing evaluation of cardiovascular outcomes trials and recommendations from the ..