WASHINGTON: The U.S. Food and Drug Administration (FDA) has approved Lilly’s Mounjaro to reduce the risk of heart attacks and strokes in adults with type 2 diabetes who face a high risk of cardiovascular problems, expanding the drug’s role beyond blood sugar control.
The FDA’s decision, announced on Friday, Aug. 28, follows results from a major clinical trial in which Mounjaro performed better than Lilly’s older diabetes medicine. The study found that Mounjaro reduced major heart-related complications by 8% more than Trulicity.
Mounjaro, whose active ingredient is tirzepatide, belongs to a class of medicines known as GLP-1 receptor agonists. The drug is used to improve blood sugar levels in people with type 2 diabetes. Tirzepatide is also marketed by Lilly as Zepbound, which is approved for chronic weight management.
The approval also comes as demand for Lilly’s medicines continues to surge. Mounjaro sales jumped 91% to $9.94 billion in the second quarter, helped by strong demand worldwide, according to Reuters reports.
Lilly’s expansion into cardiovascular care comes as it competes with Danish drugmaker Novo Nordisk, which has also been developing broader uses for its GLP-1 medicines. The FDA approved Novo Nordisk’s Wegovy in 2024 to reduce the risk of major cardiovascular events in certain adults with obesity and established heart disease.
The two pharmaceutical companies are increasingly testing GLP-1 medicines for conditions beyond diabetes and weight management, including cardiovascular disease and liver disorders. Their efforts reflect growing interest in the wider health benefits of drugs that were initially developed to control blood sugar.
Mounjaro was first approved by the FDA in 2022 for improving blood sugar control in adults with type 2 diabetes. Since then, tirzepatide has become one of the most closely watched medicines in the rapidly expanding GLP-1 market.
