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FDA Issues New Draft Guidance on T2D Medication Safety Trials


The FDA announced a new draft guidance to consider broader evaluations beyond cardiovascular outcomes trials for type 2 diabetes (T2D) medications.

The FDA announced a new draft guidance to consider broader evaluations beyond cardiovascular outcomes trails for type 2 diabetes (T2D) medications.

The guidance entitled, “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” aims to solicit public comment on proposals for broad safety evaluations prior to drug approvals. In addition to patients with cardiovascular disease, the guidelines single out older patients and those with chronic kidney disease who may be vulnerable to drug-related side effects.

The relationship between cardiovascular disease, kidney disease, and diabetes has been well-documented and researchers have found chronic kidney disease may even be a cause of diabetes. Patients with T2D also suffer from serious medical complications and comorbidities, such as nerve damage, kidney and eye damage, sleep apnea, and heart and blood vessel disease.

However, the new draft guidance does not recommend sponsors of all new therapies for T2D “uniformly rule out a specific degree of risk for ischemic cardiovascular adverse outcomes,” recommended in previous guidance.

The new draft replaces 2 previous industry guidances, both published in 2008: “Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” and “Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention.”

The decision comes after the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee noted the need for safety data beyond that of cardiovascular safety is required to evaluate antidiabetic drugs before they are approved.

“By following previous FDA recommendations, sponsors have shown that new T2D drugs do not have excess ischemic cardiovascular risk, which has provided reassuring cardiovascular safety information for millions of diabetes patients,” said Lisa Yanoff, MD, acting director of the FDA’s division for metabolism and endocrinology products. “Now, with this proposed approach, we will have broader, valuable safety information for these medications.”

Currently, over 30 million Americans have diabetes, and 90% to 95% of that population have T2D.

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