Lilly's Trulicity wins first FDA approval for CV reduction in Type 2 diabetes patients

The U.S. Food and Drug Administration (FDA) has approved Trulicity (dulaglutide) for the reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who have established cardiovascular (CV) disease or multiple cardiovascular risk factors. This decision makes Trulicity the first and only type 2 diabetes medicine approved to reduce the risk of MACE for both primary and secondary prevention populations.

The new indication reflects the differentiated patient population of REWIND (Researching cardiovascular Events with a Weekly INcretin in Diabetes), the Trulicity cardiovascular outcomes trial. While all participants had CV risk factors, the study consisted primarily of people without established CV disease. REWIND showed a significant risk reduction in MACE, a composite endpoint of heart attack, nonfatal stroke or CV death. Results demonstrated consistent MACE risk reduction with Trulicity across major demographic and disease subgroups.

According to Lilly, the trial was designed to study a broad population of people living with type 2 diabetes that reflected the general population. Globally, more than 415 million people have type 2 diabetes, which is itself a cardiovascular risk factor. However, only about one third have established cardiovascular disease.

Trulicity has been available in the U.S. since 2014 and is the number one prescribed GLP-1 RA.

Read the full Eli Lilly release.