Mounjaro receives expanded approval in South Korea for cardiovascular risk reduction

Eli Lilly Korea has announced that the Ministry of Food and Drug Safety has expanded the indications for Mounjaro (tirzepatide). The treatment is now approved for adult type 2 diabetes patients with established cardiovascular disease to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.

Additionally, the approval extends to pediatric patients aged 10 and older as an adjunct to diet and exercise for improving glycemic control in type 2 diabetes. This expansion is supported by the SURPASS-CVOT clinical trial, a large-scale study involving over 13,000 patients across 30 countries, which demonstrated Mounjaro's non-inferiority to Trulicity in reducing cardiovascular risks.

The expansion positions Mounjaro as a comprehensive option for managing blood sugar, weight, and cardiovascular health simultaneously. Industry experts note that the drug's market success in South Korea will likely depend on its inclusion in the national health insurance reimbursement list.