Overview
- Eli Lilly and the FDA announced Monday that tirzepatide (Mounjaro) may be prescribed to reduce major adverse cardiovascular events, such as heart attack and stroke, in high-risk adults with type 2 diabetes.
- The approval rests on a large active-comparator trial comparing Mounjaro with Lilly’s GLP-1 drug Trulicity, in which Mounjaro showed roughly an 8% lower rate of first major heart events using a hazard ratio near 0.92.
- Because the trial used an active comparator rather than a placebo, the 8% figure cannot be directly equated with the roughly 20% reductions reported in placebo-controlled trials of some Novo Nordisk incretin drugs.
- Mounjaro’s growing clinical role comes as its sales surged, with second-quarter revenue reported at about $9.94 billion, and Lilly is running follow-up studies testing cardiovascular and kidney outcomes for Mounjaro/Zepbound and other investigational drugs.
- Clinicians and regulators will continue post-market safety monitoring and await results from broader trials in people without diabetes and late-stage studies of Lilly’s next-generation cardiometabolic medicines to clarify longer-term benefits and risks.