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#LLY — FDA Expands Mounjaro Approval to Reduce Cardiovascular Risk | ThinkSabio
Aug 28, 2026 · ThinkSabio Inc
Eli Lilly (#LLY) received FDA approval to expand the indication for Mounjaro (tirzepatide) to reduce the risk of major cardiovascular events in adults with type 2 diabetes who are at high cardiovascular risk.
🔹 Key Highlights
💊 FDA approved Mounjaro to reduce major adverse cardiovascular events.
❤️ The indication covers cardiovascular death, non-fatal heart attack, and non-fatal stroke.
🧪 The approval was supported by the 13,299-patient SURPASS-CVOT Phase 3 trial.
📊 Mounjaro demonstrated non-inferiority to Trulicity for the cardiovascular endpoint.
📈 Superiority over Trulicity was not established.
💰 Mounjaro sales reached $9.94B in Q2, up 91% YoY, according to Reuters.
🩺 The expanded indication adds another major clinical benefit to Lilly's blockbuster diabetes and weight-management franchise.
💡 Why It Matters
The expanded FDA indication broadens Mounjaro's commercial opportunity beyond glucose control and weight loss into cardiovascular risk reduction. It also strengthens Lilly's competitive position in the rapidly expanding GLP-1 market.
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