The decision gives physicians a new tool to address a leading cause of mortality in type 2 diabetes patients, who face significantly elevated cardiovascular risk compared with the general population. It also deepens Lilly’s lead in the increasingly competitive incretin market, where Mounjaro recently overtook MSD’s Keytruda as the world’s top-selling branded drug.
Clinical Evidence Behind the Approval
The FDA based its decision on results from the SURPASS-CVOT trial (NCT04255433), which compared Mounjaro against Lilly’s older GLP-1 receptor agonist Trulicity (dulaglutide). The study showed tirzepatide reduced the combined rate of cardiovascular death, heart attack, or stroke by 8 percent relative to dulaglutide, which itself received cardiovascular risk reduction clearance in 2020.
David D’Alessio, study co-author and director of endocrinology and metabolism at Duke University School of Medicine, framed the approval as a meaningful shift in how diabetes care is delivered. “Mitigating cardiovascular risk is essential and can be overlooked,” he said, noting that much of type 2 diabetes management has historically centered on glucose control rather than downstream cardiovascular outcomes.
“This approval gives patients a medicine that reduces the risk of cardiovascular events and supports metabolic health at the same time,” D’Alessio added, underscoring the dual benefit clinicians can now offer in a single injectable therapy.
How Mounjaro Differs From Wegovy
Mounjaro’s distinction lies in its mechanism. The drug targets both gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptors, a dual pathway that distinguishes it from Novo Nordisk’s Wegovy (semaglutide), which acts only on GLP-1 receptors. Wegovy secured its own cardiovascular risk reduction indication in the US in March 2024.
The competitive gap between the two therapies is narrowing as both manufacturers push beyond weight loss into broader cardiometabolic territory. Analysts increasingly view cardiovascular protection, muscle mass retention, and physical function improvements as the next battleground for incretin therapies, rather than appetite suppression alone.
Commercial Momentum for Lilly
The label expansion arrives during a standout financial year for Lilly. Mounjaro sales surged 91 percent to $9.9 billion in the second quarter alone, prompting the company to raise its full-year outlook for the second time in August. The cardiovascular indication adds a fresh commercial lever to a product that has already reshaped the global blockbuster landscape.
GlobalData projects that GLP-1 receptor agonist sales across type 2 diabetes and obesity markets will exceed $125 billion by 2033 across the seven major markets — the US, France, Germany, Italy, Spain, the UK, and Japan. That forecast underscores the scale of the opportunity Lilly and Novo Nordisk are contesting.
Novo Nordisk, meanwhile, has faced headwinds. The Danish manufacturer has reported slowing weight loss sales growth and mixed trial results for newer candidates, though its oral semaglutide formulation has shown early promise, with millions of US prescriptions filled since launch earlier this year.
What Happens Next
Clinicians will now weigh Mounjaro’s cardiovascular benefit against existing options when treating type 2 diabetes patients with elevated heart risk, and payers will likely revisit formulary decisions as the indication broadens Mounjaro’s value proposition beyond glucose control. Watch for updated treatment guidelines from cardiology and endocrinology societies, which typically follow major label expansions within months.
For Lilly, the next test is whether the cardiovascular indication accelerates prescribing among cardiologists — a prescriber base the company has historically reached less effectively than endocrinologists. Novo Nordisk’s response, including any head-to-head data positioning Wegovy against Mounjaro on cardiovascular outcomes, will shape the competitive dynamic through 2025 and beyond.
— Aisha Mensah, health desk, AXO News