Eli Lilly (LLY) has secured FDA approval to expand the label for its blockbuster diabetes drug Mounjaro to cover cardiovascular risk reduction in at-risk adults with type 2 diabetes.
The approval allows Mounjaro to be used to reduce the risk of major adverse cardiovascular events, including cardiovascular death, heart attack, and stroke, in eligible patients.
The decision puts Lilly on equal footing with rival Novo Nordisk (NVO), which received a similar cardiovascular endorsement for its diabetes drug Ozempic back in 2020.
Both companies achieved their respective cardiovascular label expansions on broadly similar timelines, with Novo reaching its endorsement three years after Ozempic’s original approval and Lilly reaching its four years after Mounjaro’s first clearance.
Lilly says the significance of the approval is underscored by estimates that one in every three people with type 2 diabetes also have undetected cardiovascular disease.
The Indianapolis-based company argues its approval carries additional weight because it was achieved through the first-ever head-to-head cardiovascular outcomes trial between two incretin medicines, rather than a comparison against placebo.
“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,” said Kenneth Custer, Ph.D., Lilly’s head of Cardiometabolic Health.
The approval was based on results from the SURPASS-CVOT trial, a randomised, double-blind, Phase 3 study that enrolled 13,299 participants across 30 countries over roughly five years.
The trial compared Mounjaro against Trulicity, a GLP-1 treatment with established cardiovascular benefit, with Mounjaro demonstrating an 8% lower rate of cardiovascular death, heart attack, or stroke.
The estimated hazard ratio for time to first major adverse cardiovascular event was 0.92 for Mounjaro compared to Trulicity, though superiority over Trulicity was not demonstrated.
Lilly is positioning Mounjaro as the first and only GIP and GLP-1 receptor agonist proven to lower the risk of heart attack, stroke, or cardiovascular death in adults with type 2 diabetes who are at high risk.
The label expansion places Mounjaro alongside Novo’s semaglutide products, Ozempic and Wegovy, in the growing cardiovascular treatment space for metabolic conditions.
Wegovy was approved to treat adults with heart disease and overweight or obesity, while Ozempic is approved to reduce cardiovascular event risk in adults with type 2 diabetes and established cardiovascular disease.
The commercial backdrop for Mounjaro remains exceptionally strong, with sales rising 91% to $9.94 billion in the second quarter driven by robust global demand.
The cardiovascular label expansion is expected to broaden Mounjaro’s prescribing reach further, giving clinicians an additional clinical reason to favour it in high-risk diabetic patient populations.