USFDA approves Eli Lilly's Trulicity (dulaglutide) for reduction in MACE in type 2 diabetes patient

Indianapolis: 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 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.

"The trial was designed to study a broad population of people living with type 2 diabetes, reflective of those in the general population. We, therefore, assessed the effect of Trulicity in people with established cardiovascular disease as well as those with multiple cardiovascular risk factors," said Hertzel Gerstein, M.D., MSc, FRCPC, professor of medicine and deputy director of the Population Health Institute at McMaster University and Hamilton Health Sciences, and the REWIND study chair. "Globally, over 415 million people have type 2 diabetes, which is itself a cardiovascular risk factor. However, only about one third have established cardiovascular disease, which is why this new indication, and the supporting evidence, is important for the millions of people in the U.S. living with diabetes."

"For the first time, health care providers can prescribe a diabetes medicine proven to significantly reduce the risk of experiencing a cardiovascular event for people with type 2 diabetes with and without established cardiovascular disease," said Sherry Martin M.D., vice president, medical affairs, Lilly. "Trulicity can help people achieve their A1C goals and protect them from experiencing a cardiovascular event with a once-weekly, easy-to-use treatment option."

Trulicity has been available in the U.S. since 2014 and is the number one prescribed GLP-1 RA. In addition to its proven glycemic efficacy and easy-to-use device, Trulicity can now be prescribed to help people with type 2 diabetes reduce their risk of CV events.

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