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Eli Lilly's Mounjaro receives FDA approval to reduce cardiovascular risk
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s diabetes medication, Mounjaro (tirzepatide), to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who are at high risk. The approval includes reducing the risk of cardiovascular death, non-fatal heart attack, and non-fatal stroke.
The decision follows the SURPASS-CVOT phase 3 clinical trial, which involved over 13,000 participants across 30 countries. In a head-to-head comparison with Lilly’s older drug, Trulicity (dulaglutide), Mounjaro demonstrated an 8% lower rate of MACE. Additionally, the trial reported a 16% reduction in deaths from any cause among patients using Mounjaro.
This regulatory expansion shifts Mounjaro’s clinical profile from glycemic and weight management to include cardioprotection. This move intensifies competition in the GLP-1 market, where Novo Nordisk already holds similar approvals for drugs like Wegovy and Rybelsus. Eli Lilly has seen significant financial growth from its incretin therapies, with Mounjaro sales reaching $9.94 billion in the second quarter of 2026.
Entities
Eli Lilly and Company · FDA · Mounjaro · Novo Nordisk · ReviR Therapeutics · Roivant Sciences · Trulicity · U.S. Food and Drug Administration
Claims
What the coverage asserts, and how many sources carry each claim.
- [● 4 SOURCES] The SURPASS-CVOT trial showed Mounjaro had an 8% lower rate of major adverse cardiovascular events compared to Trulicity. www.brasilemfolhas.com.br · www.consultantlive.com · www.finanzen.at · www.upday.com
- [● 2 SOURCES] Patients receiving Mounjaro had a 16% lower rate of death from any cause compared to those receiving Trulicity. www.capital.gr · www.upday.com
- [○ 1 SOURCE] Mounjaro generated over $18.6 billion in sales during the first half of 2026. www.upday.com
- [● 2 SOURCES] Mounjaro sales grew 91% in the second quarter, reaching US$ 9.94 billion. www.brasilemfolhas.com.br · www.it-boltwise.de
- [● 8 SOURCES] The FDA approved Mounjaro to reduce the risk of cardiovascular death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes at high risk for these events. www.brasilemfolhas.com.br · www.sbctv.gr · www.it-boltwise.de · www.capital.gr · www.consultantlive.com · +3 more
- [● 4 SOURCES] The SURPASS-CVOT trial included more than 13,000 participants across 30 countries. www.capital.gr · www.consultantlive.com · www.finanzen.at · www.upday.com