US FDA Guidance for Industry on Diabetes Therapies- Revisited

Amidst the continuous development of newer oral anti-diabetic agents, today we are going to revisit a significant guidance draft that was issued by The US Food and Drug Administration (USFDA) on the evaluation of new anti-diabetic drugs.

The guidance titled "Type 2 Diabetes Mellitus (T2DM): Evaluating the Safety of New Drugs for Improving Glycemic Control” was issued by USFDA in 2020 and emphasized on Broader Evaluations Beyond Cardiovascular Outcomes Trials. With this, the draft replaced the outdated requirement that manufacturers conduct cardiovascular outcome trials to rule out unacceptable cardiovascular safety risk.

The move came in the light of the fact that since the earlier released US FDA guidance draft (2008), none of the CVOTs conducted have identified an increased risk of ischemic cardiovascular events. “Some of the CVOTs have instead demonstrated a reduced risk for CV events" the US FDA 2020 draft guidance added.

The FDA draft guidance recommends an updated approach for evaluating the safety profile of anti-hyperglycemic agents. The recommendations include enrolling a broader spectrum of patients with comorbidities and diseases linked to diabetes, including older individuals and those with underlying renal and cardiovascular co-morbidities.