Eli Lilly’s Trulicity approved in US to reduce cardiovascular events in type 2 diabetes patients

pharmafile | February 24, 2020 | News story | Sales and Marketing Eli Lilly, Trulicity, cardiovascular disease, pharma 

Eli Lilly’s Trulicity (duraglutide) has been awarded marketing authorisation from the FDA as a therapy to reduce major adverse cardiovascular events (MACE) in type 2 diabetes (T2D) patients with established cardiovascular (CV) disease or who exhibit multiple cardiovascular risk factors, it has been announced.

According to the manufacturer, this makes Trulicity the first and only type 2 diabetes therapy approved for this indication in primary and secondary prevention populations. It secured its first approval in the US back in 2014.

“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,” commented Dr Sherry Martin, Vice President of Medical Affairs at 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.”

This latest approval is based on data generated from a recent study of Lilly’s drug in participants primarily free of established CV disease. Trulicity was shown to significantly and consistently reduce MACE across “major demographic and disease sub-populations”, while its safety profile was found to be in line with those of other GLP-1 receptor agonists.

“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,” remarked Hertzel Gerstein, Chair of the Trulicity study and Professor of Medicine and Deputy Director of the Population Health Institute at McMaster University and Hamilton Health Sciences. “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 US living with diabetes.”

Matt Fellows

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