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News
Mounjaro makes history as the FDA expands its label to include reducing major cardiovascular events in adults with type 2 diabetes at elevated risk. Tirzepatide is now the first dual GLP-1/GIP receptor agonist with this indication, backed by the SURPASS-CVOT trial showing it was noninferior to dulaglutide in cutting CV death, heart attack, and stroke risk over four years.
The FDA has granted tirzepatide (Mounjaro) an expanded indication to reduce major adverse cardiovascular events (MACE) — including CV death, nonfatal heart attack, and nonfatal stroke — in adults with type 2 diabetes at elevated cardiovascular risk. This makes it the first dual GLP-1/GIP receptor agonist to carry this label, adding to its existing approvals for blood sugar control (ages 10+) and, as Zepbound, for weight loss and obstructive sleep apnea.
The new indication is supported by the SURPASS-CVOT trial, which enrolled 13,299 adults with type 2 diabetes and established atherosclerotic cardiovascular disease. Over a median follow-up of four years, tirzepatide proved noninferior to dulaglutide (Trulicity) — a GLP-1 agonist already approved for CV risk reduction — on the primary MACE endpoint. Side effects were largely gastrointestinal, mild-to-moderate, and mostly occurred during dose escalation.
Key Takeaways:
Why it matters: With cardiovascular disease remaining the leading cause of death in people with type 2 diabetes, expanding the toolkit for CV risk reduction is a meaningful clinical win — especially for a drug already widely used for metabolic management.
