USA – FDA Revamps Safety Testing for new Type 2 Diabetes Drugs

In a draft guidance issued Monday, the US Food and Drug administration (FDA) proposed a new, broader approach to conducting safety evaluations for new drugs to treat type 2 diabetes that looks beyond assessing cardiovascular (CV) risk.
 
Background
 
After a meta-analysis published in the New England Journal of Medicine in 2007 raised concerns that the widely-used diabetes drug Avandia (rosiglitazone) could increase the risk of myocardial infraction, FDA in issued guidance in 2008 recommending drugmakers evaluate antidiabetic drugs for cardiovascular risk by conducting cardiovascular outcome trials (CVOTs).
 
In the ensuing years, none of the CVOTs have identified an increased risk of ischemic cardiovascular events. Some of the studies actually demonstrated a decreased risk for cardiovascular events, leading FDA to approve drugs such as Boehringer Ingelheim’s Jardiance (empagliflozin) and Novo Nordisk’s Victoza (liraglutide) to reduce the risk of cardiovascular death in patients with type 2 diabetes…