Dulaglutide

In their high-profile competition in the diabetes and obesity markets, Eli Lilly has proven adept at playing catch-up with Novo Nordisk. On Friday, Lilly checked another item off that list as it secured FDA approval for Mounjaro to reduce the risk of major adverse cardiovascular events (MACE), including CV death, heart attack or stroke, in at-risk adults with Type 2 diabetes. With the nod, Lilly matches the 2020 approval Novo received for its diabetes treatment, Ozempic, to lower the risk of adverse cardiovascular events in at-risk patients. The label expansions came on similar timelines for the rivals. While Novo achieved its heart-helping endorsement three years after the FDA originally approved Ozempic, Lilly gained its expansion four years after the FDA first signed off on Mounjaro. Highlighting the significance of the nod is an estimate that one in every three people who have Type 2 diabetes also have undetected cardiovascular disease, Lilly said. The FDA approval for the Indianapolis company may carry more weight, as it was achieved through the first head-to-head cardiovascular outcomes trial between two incretin drugs as opposed to a placebo-controlled study. In the phase 3 SURPASS-CVOT trial, which enrolled 13,000 patients in 30 countries and lasted more than four years, Mounjaro showed non-inferiority to Lilly’s prior-generation GLP-1 diabetes blockbuster Trulicity. Mounjaro provided an 8% lower rate of cardiovascular death, heart attack or stroke than Trulicity, which was approved for Type 2 diabetes in 2014 and tacked on a nod to reduce cardiovascular disease in 2020. With the caveat that cross-trial comparisons are an imperfect metric, Novo’s cardio endorsement came by way of the Sustain 6 study, which showed that Ozempic achieved a 26% relative risk reduction over placebo in preventing CV events, including death, non-fatal heart attacks and non-fatal strokes. “We set a higher bar by testing Mounjaro against a GLP-1 medicine with proven cardiovascular benefit, one that reflects the depth of evidence Lilly continues to build in this field,” Kenneth Custer, Ph.D., Lilly’s head of Cardiometabolic Health, said in a statement. This marks the first label expansion for Mounjaro. In 2024, Lilly’s obesity treatment Zepbound, which is the same compound (tirzepatide) as Mounjaro, scored an expansion for sleep apnea. In addition to Ozempic’s cardio expansion, the FDA signed off on the drug to reduce the risk of kidney disease and cardiovascular death in those with Type 2 diabetes and chronic kidney disease in 2025. A year before that, Novo’s obesity treatment Wegovy scored an expansion to reduce cardiovascular risk in those who are overweight or obese and followed last year with a nod to treat metabolic dysfunction-associated steatohepatitis (MASH).

More than two years after Novo Nordisk won a cardiovascular (CV) label expansion for Wegovy (semaglutide), Eli Lilly has finally bagged a similar approval for its GLP-1/GIP dual agonist. The FDA on Friday approved Lilly's Mounjaro (tirzepatide) to lower the risk of major adverse CV events (MACE), including CV death, non-fatal heart attack, or non-fatal stroke in high-risk adults with type 2 diabetes. While Novo's CV clearance, granted by the US regulator in early 2024, was attached to the Wegovy brand of semaglutide marketed to patients with obesity, Lilly won its CV nod for the brand of tirzepatide approved for people with diabetes, rather than the weight-loss Zepbound drug (see – New study maps broader potential for GLP-1s – plus emerging risks).Lowering the risk of deathMounjaro's CV nod relied on data from the four-year Phase III SURPASS-CVOT study, which enrolled over 13,000 adults across 30 countries with type 2 diabetes and established atherosclerotic CV disease. The trial compared Mounjaro against Lilly's earlier GLP-1 drug Trulicity (dulaglutide), approved for both type 2 diabetes and CV risk reduction. Lilly reported last year the trial met its primary endpoint by demonstrating that patients taking Mounjaro experienced an 8% lower rate of MACE — including CV death, heart attack or stroke — meeting the statistical threshold for non-inferiority to Trulicity. The GLP-1/GIP agonist was also associated with a 16% reduction in all-cause mortality."While a large portion of type 2 diabetes care is focused on glucose control, mitigating cardiovascular risk is essential and can be overlooked," said David D'Alessio, co-author of the SURPASS-CVOT study. "This approval gives patients a medicine that reduces the risk of cardiovascular events and supports metabolic health at the same time."