The US Food and Drug Administration (FDA) has approved Eli Lilly's blockbuster type 2 diabetes therapy, Mounjaro (tirzepatide), as a treatment for cardiovascular risk reduction in patients with the cardiometabolic condition – expanding the drug's label following its rise to become the top-selling prescription medication in the world.
Following the agency's regulatory blessing, physicians can now prescribe the dual gastric inhibitory polypetide (GIP) and glucagon-like peptide 1 (GLP-1)-targeting injectable to American type 2 diabetic adults with the intention of lowering a patient's risk of major cardiovascular events. This includes heart attack, stroke and death.
With the approval, Mounjaro has become the GIP and GLP-1-targeting therapy to secure the US regulatory go-ahead for major cardiovascular event risk reduction. Novo Nordisk's rival product Wegovy (semaglutide), which targets GLP-1 receptors but not GIP, won approval in this indication in the US in March 2024.
The FDA approved Mounjaro in this setting based on the outcomes of the SURPASS-CVOT study (NCT04255433), which revealed that Mounjaro lowered the rate of cardiovascular death, heart attack or stroke by 8% compared to Lilly's predecessor GLP-1 receptor agonist (GLP-1RA), Trulicity (dulaglutide).
Trulicity, part of the older generation of GLP-1RAs, was originally given the FDA go-ahead for cardiovascular risk reduction in type 2 diabetes back in 2020.
According to study co-author and director of endocrinology and metabolism at the Duke University School of Medicine, David D'Alessio, this is an important step forward for the type 2 diabetes field, as a large portion of care is focused on glucose control. "Mitigating cardiovascular risk is essential and can be overlooked," he commented.
"This approval gives patients a medicine that reduces the risk of cardiovascular events and supports metabolic health at the same time," D'Alessio added.
Mounjaro's US approval for cardiovascular risk reduction will likely be notable as experts increasingly look to the impact of incretin therapies past weight loss – focusing on factors like cardiovascular risk, muscle mass retention and improvements in physical activity.
Mounjaro's label expansion comes as both Lilly and staunch obesity rival, Novo Nordisk race to fortify their weight loss empires, as the pair battle it out to secure market share in the lucrative space. A recent report from GlobalData forecasted that the GLP-1RA sales across the type 2 diabetes and obesity markets will reach over $125 billion within the seven major markets alone (7MM: 7MM- US, France, Germany, Italy, Spain, UK, and Japan) by 2033, reflecting the lucrative market they are operating in.
With Mounjaro recently dethroning MSD's Keytruda (pembrolizumab) as the best-selling branded drug, and this new indication under its belt, the therapy could be set for further commercial success. Lilly raised its outlook for the second time in August as Mounjaro's sales soared 91% to reach $9.9bn in Q2 alone – besting analyst expectations and setting the course for a standout financial year for Lilly.
Meanwhile, it's been a little tougher for Novo Nordisk, which has struggled with dwindling weight loss sales growth, as well as mixed trial results for its new weight loss products. However, the company is seeing promising signs of early success for its approved GLP-1RA pill, oral Wegovy (semaglutide), which has filed millions of US prescriptions since its launch earlier this year.
"Lilly's Mounjaro wins US label expansion for cardiovascular risk reduction" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.