FDA approves Mounjaro to cut cardiovascular risk by 8% in high-risk diabetes patients

  • FDA approves Eli Lilly Mounjaro to reduce cardiovascular risk in type 2 diabetes.
  • SURPASS-CVOT showed an 8% lower major adverse event rate versus Trulicity.
  • Mounjaro generated $9.94 billion in second-quarter global revenue.

The U.S. Food and Drug Administration approved Eli Lilly’s Mounjaro (tirzepatide) to reduce the risk of cardiovascular death, nonfatal heart attack and nonfatal stroke in adults with type 2 diabetes who have established heart disease or elevated cardiovascular risk, making it the first dual GIP/GLP-1 receptor agonist cleared for that purpose in the United States. The decision rested on SURPASS-CVOT, a 13,299-patient outcomes trial across 30 countries that compared Mounjaro with Trulicity and found an 8% lower rate of major adverse cardiovascular events, meeting non-inferiority though not statistical superiority; a separate company-cited analysis showed a 16% reduction in all-cause mortality. Already the most prescribed branded adult type 2 diabetes medicine in the U.S. and a major growth engine alongside obesity drug Zepbound, Mounjaro posted $9.94 billion in second-quarter global revenue, and the expanded label strengthens Lilly’s case for insurance coverage versus weight-loss-only use while intensifying competition with Novo Nordisk’s GLP-1 franchise.

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