FDA approves Trulicity to reduce major adverse cardiovascular events in type 2 diabetes patients Eli Lilly

The 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 Eli Lilly and Company's 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, 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 nonfatal myocardial infarction (heart attack), nonfatal stroke or CV death. Results demonstrated consistent MACE risk reduction with Trulicity across major demographic and disease subgroups. Trulicity's safety profile was consistent with the GLP-1 receptor agonist (RA) class. The most common adverse events leading to the discontinuation of Trulicity were gastrointestinal events.