Eli Lilly’s Mounjaro wins FDA approval for a major new cardiovascular benefit

Eli Lilly’s blockbuster diabetes drug Mounjaro has gained a major new use in the United States after the Food and Drug Administration approved it to help reduce the risk of heart attack and stroke in adults with type 2 diabetes who face a high risk of cardiovascular events.

The decision gives Lilly another important foothold in the rapidly expanding market for GLP-1 medicines, where drugmakers are increasingly seeking to prove that the benefits of these treatments extend well beyond blood sugar control and weight loss.

Mounjaro, known chemically as tirzepatide, is already widely used to treat type 2 diabetes. The same active ingredient is also sold by Lilly under the brand name Zepbound for weight management.

Mounjaro beats Lilly’s older diabetes drug in major study

The FDA’s decision was supported by results from a large head-to-head clinical trial comparing Mounjaro with Trulicity, Lilly’s older diabetes medicine.

The study found that patients taking Mounjaro had an 8% greater reduction in the risk of major cardiovascular events, including heart attack and stroke, compared with those treated with Trulicity.

The result gives Lilly a significant new clinical argument for Mounjaro at a time when GLP-1 drugs are being tested for an expanding range of health conditions.

For millions of people living with type 2 diabetes, cardiovascular disease remains one of the most serious long-term health concerns. A drug that can address blood sugar while also lowering the risk of major heart-related events could therefore become increasingly important in treatment decisions.

Why the FDA approval matters for Eli Lilly

Mounjaro has already become one of Eli Lilly’s biggest growth engines.

Demand for the drug has surged worldwide, helping drive a sharp increase in sales. Mounjaro revenue climbed 91% to $9.94 billion in the second quarter as prescription volumes continued to rise across global markets.

The new cardiovascular indication could further broaden the drug’s use and strengthen Lilly’s position in its battle with Danish pharmaceutical giant Novo Nordisk.

The two companies dominate the market for a new generation of medicines that mimic hormones involved in appetite, blood sugar and metabolic regulation.

But the competition is increasingly moving beyond weight loss.

Drugmakers are now racing to show that their treatments can also help prevent serious diseases and improve long-term health outcomes.

GLP-1 drugs are moving beyond weight loss

The latest Mounjaro approval comes as the medical potential of GLP-1 drugs continues to expand.

Novo Nordisk secured FDA approval in 2024 for Wegovy to reduce cardiovascular risk in certain adults who are overweight or obese and do not have diabetes.

The following year, the FDA approved Novo Nordisk’s diabetes drug Rybelsus for reducing the risk of major cardiovascular events in patients with diabetes.

Lilly and Novo Nordisk are now studying their leading medicines in a growing list of conditions, including cardiovascular disease and liver disorders.

That research reflects a broader shift in the pharmaceutical industry’s approach to GLP-1 treatments.

What began as a class of drugs primarily associated with diabetes management has evolved into one of the most competitive areas of medicine, with companies investigating whether the drugs can influence a far wider range of health problems.

A bigger role for Mounjaro

For Eli Lilly, the new FDA decision could make Mounjaro more than just a diabetes treatment with a secondary connection to weight loss.

The approval formally recognises its potential role in reducing the risk of some of the most serious complications faced by high-risk patients with type 2 diabetes.

It also gives doctors another factor to consider when choosing between an increasingly crowded field of diabetes and GLP-1 medicines.

As Lilly and Novo Nordisk continue to test their drugs against heart disease, metabolic disorders and other conditions, the competition may increasingly depend on which company can demonstrate the broadest benefits.

For now, Mounjaro has added another major FDA-approved use — and Eli Lilly has gained fresh momentum in the high-stakes race to define what the next generation of GLP-1 drugs can do.

(With Reuters inputs)