The US Food and Drug Administration (FDA) on Friday released an updated draft guidance to help sponsors demonstrate efficacy for new antidiabetic drugs and biologics for adults and children with type 1 and type 2 diabetes.
The draft guidance replaces a previous version issued in 2008 guidance, which was withdrawn in 2020 because its safety recommendations were outdated. Endpoints related to clinical complications or preventing Type 1 diabetes and issues related to statistical analysis are outside the scope of the guidance.
“Diabetes is a common disease that affects nearly 40 million people in the U.S. and is projected to affect more in the coming years. The need for more antidiabetic treatment options is clear,” said Lisa Yanoff, deputy director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the FDA’s Center for Drug Evaluation and Research (CDER). “Today’s draft guidance demonstrates the FDA’s ongoing commitment to providing industry with up-to-date recommendations on how to approach developing new drug therapies.”…
