FDA approves Mounjaro to lower heart-attack, stroke and cardiovascular death risk in adults with type 2 diabetes

Eli Lilly/Tirzepatide (Mounjaro / Zepbound)

The FDA approved tirzepatide (Mounjaro) to reduce major adverse cardiovascular events in adults with type 2 diabetes who are at high risk for them. The approval rests on SURPASS-CVOT, which compared tirzepatide with dulaglutide in more than 13,000 people.

• SURPASS-CVOT enrolled more than 13,000 participants and compared tirzepatide with dulaglutide (Trulicity), not with placebo.
• The hazard ratio for major cardiovascular events was 0.92 (95% CI 0.83 to 1.01): non-inferior to dulaglutide, but superiority was not shown.
• The new label adds cardiovascular risk reduction to Mounjaro's use for blood-sugar control.