FDA Expands Mounjaro Label to Reduce Heart Attack and Stroke Risk in Type 2 Diabetes Patients

The FDA approved an expanded label for Eli Lilly's Mounjaro (tirzepatide) to reduce major adverse cardiovascular events, including heart attack and stroke, in high-risk patients with type 2 diabetes. The decision was supported by the SURPASS-CVOT trial, which enrolled more than 13,000 patients and showed Mounjaro delivered an 8% lower cardiovascular event rate compared with dulaglutide, alongside improvements in blood sugar control and weight loss. Mounjaro is now the first dual GIP/GLP-1 receptor agonist to carry a cardiovascular risk-reduction indication, strengthening Lilly's competitive position in a market that includes roughly one in three U.S. adults with type 2 diabetes who have undetected heart disease.

Shares of Lilly rose about 0.8% in premarket trading following the announcement. In other pharma news, Roivant and Priovant launched their newly approved rare disease drug Lisraya at $35,000 per month, and Amgen and AstraZeneca reported a late-stage trial win for their asthma drug Tezspire in a swallowing disorder.