FDA expands Mounjaro label to cut cardiovascular death risk in type 2 diabetes
The approval rests on a trial of more than 13,000 patients showing 8% fewer major cardiovascular events versus Lilly's older Trulicity, not placebo.
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By Daniel Okafor · Regulatory Correspondent
Sep 1 03:00 ETSource: 24/7 Wall St.
The wire
- 01On August 28, 2026, the FDA expanded Mounjaro's label to include reducing risk of cardiovascular death, heart attack and stroke in adults with type 2 diabetes at high cardiovascular risk.
- 02The claim covers the diabetes indication, not Zepbound for obesity, giving Lilly medical-necessity language as employer GLP-1 coverage fell from 72% in 2025 to 60% in 2026.
- 03The 8% reduction was measured against an active comparator rather than placebo, and roughly 14% of surveyed employers have dropped or plan to drop the drugs in 2027.
From the source
Read at 247wallst.comInsurers Are Pulling Back From GLP-1 Drugs. The FDA Just Handed Eli Lilly Its Best Weapon Yet
Employer coverage of GLP-1 drugs is collapsing heading into 2027, but the FDA just gave Eli Lilly a specific piece of ammunition that could change the conversation in payer meetings for at least one slice of that market.
