The approval allows Mounjaro to be used to reduce the risk of heart attack, stroke and cardiovascular death in high-risk adults with type 2 diabetes.
The US Food and Drug Administration (FDA) has approved Eli Lilly’s Mounjaro (tirzepatide) to reduce the risk of major cardiovascular events in adults with type 2 diabetes who are considered at high risk of heart-related complications.
The decision expands the role of Mounjaro beyond blood sugar management and weight-related treatment, giving the drug a new indication focused on cardiovascular risk reduction.
Mounjaro Shown to Lower Major Heart Risks
The FDA’s decision was based on results from the SURPASS-CVOT cardiovascular outcomes trial, which followed more than 13,000 patients across 30 countries for five years.
The trial directly compared Mounjaro with Trulicity (dulaglutide), another medicine in the incretin class, rather than comparing the drug with a placebo.
According to the findings cited by Lilly, Mounjaro reduced the combined risk of cardiovascular death, heart attack or stroke by 8% compared with Trulicity.
The company described Mounjaro as the first GIP and GLP-1 receptor agonist shown in a cardiovascular outcomes trial to reduce the risk of these major events in adults with type 2 diabetes who are at high risk.
Why the Approval Matters
Cardiovascular disease is a major health concern for people living with type 2 diabetes. Elevated blood sugar, along with other conditions that can accompany diabetes, can increase the risk of heart disease and stroke.
Kenneth Custer, president of Cardiometabolic Health at Eli Lilly, said heart disease remains the leading cause of death among people with type 2 diabetes and described the FDA decision as providing patients with an additional proven option for lowering cardiovascular risk.
The new approval could also strengthen Mounjaro’s position in the increasingly competitive market for diabetes and obesity medicines.
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Safety Profile Remains Consistent
According to the information provided by Lilly, the safety findings from the cardiovascular trial were consistent with previous studies of Mounjaro.
Gastrointestinal side effects were among the most commonly reported adverse reactions. These effects were generally described as mild to moderate.
As with other prescription medicines, the drug’s use and suitability depend on an individual patient’s medical circumstances and should be determined with a healthcare professional.
Mounjaro Sales Continue to Rise
The FDA decision comes as Mounjaro sales have continued to grow rapidly.
Lilly reported a 91% increase in Mounjaro sales to $9.94 billion in the second quarter. The strong performance reflects growing demand for tirzepatide-based treatment in diabetes and weight-management markets.
The expanded cardiovascular indication could provide another major growth opportunity for the company by allowing eligible adults with type 2 diabetes and high cardiovascular risk to use Mounjaro specifically as part of a strategy to reduce major heart-related events.
Growing Competition in Diabetes Treatment
The approval also adds another dimension to the competition between major pharmaceutical companies developing GLP-1 and related medicines.
Mounjaro’s new cardiovascular indication places it alongside established therapies that have demonstrated cardiovascular benefits in people with type 2 diabetes.
For patients and doctors, the availability of treatments with both glucose-lowering effects and demonstrated cardiovascular benefits could increasingly influence decisions about diabetes management.
However, the FDA approval applies specifically to adults with type 2 diabetes who are at high risk of major cardiovascular events. It does not mean that Mounjaro is intended to prevent heart disease in the general population.
