Eli Lilly and CompanyFDA approval expands Mounjaro's indication to reduce cardiovascular risk, broadening eligible patients and driving prescription growth.
The FDA has approved Eli Lilly's Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type II diabetes who are at high risk for major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack, and non-fatal stroke. The approval was based on the phase III SURPASS-CVOT study, which enrolled 13,299 adults and compared Mounjaro with Lilly's Trulicity, showing an 8% lower rate of major adverse cardiovascular events with a hazard ratio of 0.92, though superiority was not established. This expanded indication strengthens Lilly's position in the cardiometabolic market and broadens the eligible patient pool, potentially driving further prescription growth. Mounjaro generated worldwide revenues of $18.6 billion in the first half of 2026, up 106% year over year, and the new label could provide an additional sales catalyst. The approval also narrows the indication gap with Novo Nordisk's Ozempic, which retains an edge in cardiovascular and kidney-related indications, while Mounjaro's momentum contrasts with Ozempic's adjusted first-half 2026 sales of $9.21 billion, down 2% at constant exchange rates.
Eli Lilly and CompanyFDA approval expands Mounjaro's indication to reduce cardiovascular risk, broadening eligible patients and driving prescription growth.
Novo Nordisk A/SLilly's approval narrows indication gap with Ozempic, which faces declining sales and increased competitive pressure.
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