The approval for Trulicity in the new indication is for type 2 diabetes with established cardiovascular (CV) disease or multiple cardiovascular risk factors.
The glucagon-like peptide 1 receptor agonist (GLP-1 RA) was approved by the FDA in 2014 as a treatment option for type 2 diabetes in adults.
Its expanded indication makes it the first and only type 2 diabetes drug to be approved for cutting down the chances of MACE in primary and also 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.”
The expanded approval for the drug has been driven by the results of its cardiovascular outcomes phase 3 trial called REWIND. The trial demonstrated the Lilly drug to have significantly brought down the risk in MACE, a composite endpoint of heart attack, nonfatal stroke or cardiovascular death.
Results from the late-stage trial showed consistent MACE risk reduction with Trulicity in major demographic and disease subgroups. Furthermore, Trulicity’s safety profile was also found to be 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.”