The U.S. Food and Drug Administration (FDA) has announced its approval of the diabetes drug Mounjaro to reduce the risk of major cardiovascular events in adults with type 2 diabetes.
Type 2 diabetes increases the risk of heart disease and stroke, with heart disease being the leading cause of death in this group, according to Eli Lilly, the manufacturer of Mangaro.
This approval comes as pharmaceutical companies manufacturing GLP-1 drugs seek to expand their therapeutic uses to include not only diabetes and obesity, but also heart, kidney, liver and sleep disorders.
This approval is the first of its kind for a drug that combines two naturally occurring hormones responsible for regulating blood sugar and appetite in the body: GLP-1 and GIP. Combining them makes the drug more effective than drugs that rely on only one of them.
“We have set a new benchmark by testing Manjaro against another GLP-1 drug with proven cardiac benefits, reflecting the depth of evidence that Lilly continues to build in this area,” explained Kenneth Custer, executive vice president and president of Eli Lilly’s Heart & Metabolic Health division, in a statement announcing this first-of-its-kind approval.
Mangaro was tested against Trulicity, another GLP-1 drug produced by Eli Lilly that improves blood sugar regulation in people with type 2 diabetes and reduces the risk of major cardiovascular events.
In a four-and-a-half-year trial involving more than 13,000 participants from 30 countries, Eli Lilly researchers found that Mangaro outperformed Trulicity in reducing the risk of heart attacks and strokes, lowering the risk of major adverse cardiac events by 8% more than Trulicity.
"Heart health deserves attention throughout the course of treatment, not just after a serious cardiac event," said Dr. David D'Alessio, director of the Division of Endocrinology and Metabolism at Duke University School of Medicine and co-author of the study. "This approval gives patients a drug that reduces the risk of cardiac events and supports metabolic health at the same time."
These findings build upon years of research demonstrating multiple cardiac benefits of GLP-1 antibody treatments for weight loss. Although Mangaro is not approved for weight loss, it is sometimes used off-label for this purpose, and Eli Lilly sells an obesity-specific version of the drug under the name Zepbound.
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