FDA Approves Dulaglutide for Adults With T2D, Regardless of CVD

The FDA approved Eli Lilly’s dulaglutide (Trulicity) for the reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes (T2D), with and without established cardiovascular disease (CVD), according to a press release. The new indication can now be used in patients with T2D and multiple CV risk factors, making it the first T2D medicine approved to reduce MACE risks in primary and secondary prevention populations.

The approval is based on results from the Researching cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial, which tested the drug on patients with and without established CVD.

All participants had CV risk factors and researchers found a significant reduction of MACE across demographic and disease subgroups. In particular, trial results showed dulaglutide reduced CV events by 12% in the study population. The leading cause of treatment discontinuation was adverse gastrointestinal events.

“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,” said Hertzel Gerstein, MD, the REWIND study chair.

Dulaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) and has been available for use in the United States since 2014. GLP-1 RAs and sodium glucose co-transporter 2 inhibitors are the leading drugs for preventing MACE in patients with T2D.

Sherry Martin, MD, vice president of medical affairs at Lilly, said of the announcement, “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.”

Dulaglutide is an injectable, once-weekly treatment, administered under the skin of a patient’s stomach, thigh, or upper arm.