Trulicity FDA approval : Eli Lilly and Company (Lilly) has secured approval from the US Food and Drug Administration (FDA) for Trulicity (dulaglutide) to reduce major cardiovascular events (MACE) in type 2 diabetes patients having established cardiovascular (CV) disease or multiple cardiovascular risk factors.
The latest FDA approval Trulicity means that the drug the first and only type 2 diabetes medicine indicated for reducing the risk of MACE for primary as well as secondary prevention populations. The Lilly diabetes drug is a weekly injectable glucagon-like peptide 1 receptor agonist (GLP-1 RA).
Sherry Martin – vice president of Lilly medical affairs, commenting on Trulicity FDA approval, 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.”
Trulicity FDA approval was driven by the results of the REWIND clinical trial in which the Lilly diabetes drug delivered a significant risk reduction in MACE, a composite endpoint of heart attack, nonfatal stroke or CV death.
The REWIND trial results showed consistent MACE risk reduction with Trulicity in major demographic and disease subgroups, said Lilly.
Hertzel Gerstein – the REWIND study chair, commenting on the latest Trulicity FDA approval 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.”