Trulicity is indicated for major adverse cardiovascular events (MACE) in type 2 diabetes patients, with cardiovascular (CV) disease or multiple cardiovascular risk factors
Eli Lilly and Company (Lilly) has secured the US Food and Drug Administration (FDA) approval for Trulicity (dulaglutide) to reduce certain cardiovascular risk factors in diabetics.
Trulicity has been indicated for reducing major adverse cardiovascular events (MACE) in type 2 diabetes patients, with cardiovascular (CV) disease or multiple cardiovascular risk factors.
The company said that its Trulicity marks the first and only approved type 2 diabetes medicine for reducing the risk of MACE for both primary and secondary prevention populations.
Lilly medical affairs vice president Sherry Martin said: “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.
“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.”
FDA approval with new indication is based on results from REWIND study
The FDA approval with a new indication is based on the results from the differentiated patient population of REWIND clinical trial, evaluating Trulicity for cardiovascular outcomes.
The REWIND study demonstrated that Trulicity significantly risk reduced MACE, a composite endpoint of nonfatal myocardial infarction (heart attack), nonfatal stroke or CV death.
In addition, the trial showed consistent MACE risk reduction across major demographic and disease subgroups with Trulicity, and its safety profile was consistent with the GLP-1 receptor agonist (RA) class.
REWIND study chair Hertzel Gerstein said: “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.
“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.”