Trulicity approved to reduce MACE in patients with T2D

The diabetes drug dulaglutide—sold commercially as Trulicity—has received an expanded indication for the reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and established CVD or CV risk factors.

Drug developer Eli Lilly reported the news Feb. 21, some six years after Trulicity was first approved by the FDA in 2014. The drug’s latest indication makes Eli Lilly’s dulaglutide the “first and only” type 2 diabetes medication approved to reduce the risk of MACE in both primary and secondary prevention populations.

The FDA approved dulaglutide’s expanded label based on the results of REWIND, a study that found patients’ risk of MACE could be reduced by around 12% with weekly injections of Trulicity. Though the findings were consistent and positive, Lilly stocks plummeted 1.4% in 2019 after the company announced the results of REWIND. Shares of Novo Nordisk, which manufactures a similar drug known as Ozempic, simultaneously climbed 2.1% in premarket trading—something Credit Suisse analyst Vamil Divan said was likely due to the fact that Novo Nordisk reported a more than doubled risk reduction with Ozempic compared to Trulicity.

It was the differentiated nature of the REWIND patient population that caught the FDA’s attention—all patients enrolled in the study had CV risk factors at baseline, but most didn’t have established CVD. Regardless, Trulicity reduced MACE across all major demographic and disease subgroups.

“The trial was designed to study a broad population of people living with type 2 diabetes, reflective of those in the general population,” Hertzel Gerstein, MD, MSc, REWIND study chair, said in a statement. “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.”

According to Eli Lilly, Trulicity is the number-one prescribed GLP-1 receptor agonist in the U.S. Dulaglutide is injected via a Trulicity pen, but ninety-four percent of people who use the drug report it’s easy to use.