The FDA has announced new recommendations on evaluating cardiovascular (CV) risk of drugs intended to treat type 2 diabetes, asking manufacturers to provide evidence that the therapy will not increase the risk of heart attacks and other events. “We need to better understand the safety of new antidiabetic drugs.
Therefore, companies should conduct a more thorough examination of their drugs’ cardiovascular risks during the product’s development stage,” said Mary H. Parks, MD, director of the FDA’s, Division of Metabolism and Endocrinology Products.
The guidance defines stronger design and data collection methods for phase 2 and phase 3 clinical trials than were previously required.
Moreover, these studies should demonstrate that new antidiabetic therapies do not increase CV risk in comparison with existing therapies, particularly when the drugs are used by elderly patients or by those with advanced diabetes or renal impairment.