Dulaglutide Receives FDA Approval for Reducing MACE in Type 2 Diabetics

With approval from the US Food and Drug Administration for the reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes, Eli Lilly and Company’s GLP-1 receptor agonist dulaglutide (Trulicity®) becomes the first type 2 diabetes medication approved to reduce risk of MACE for primary and secondary prevention populations.

In a statement from Eli Lilly and Company, the FDA’s approval of the additional indication was backed by the results of the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial, which found the treatment reduced cardiovascular disease events by 12% compared with placebo.

"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, MD, vice president of medical affairs for Eli Lilly, in the aforementioned statement. "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."

With REWIND results indicating dulaglutide can achieve meaningful reduction of a composite of MACE events in a real-world setting, the new indication for dulaglutide could be useful in addressing a treatment gap in patients with risk factors but no established cardiovascular disease. Over a period lasting more than 5 years, the REWIND trial demonstrated a reduction in cardiovascular events in the study population as well as an apparent positive effect on renal outcomes.

"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,” said Hertzel Gerstein, MD, MSc, FRCPC, REWIND study chair and deputy director of the Population Health Institute at McMaster University and Hamilton Health Sciences, in a statement.

The safety profile of dulaglutide is consistent with other GLP-1 receptor agonists—the most commonly reported adverse events leading to discontinuation was gastrointestinal events. Additionally, the FDA added a new warning for diabetic retinopathy complications.