Eli Lilly (NYSE: LLY) has secured Food and Drug Administration approval for its diabetes drug Mounjaro to reduce the risk of heart attack and stroke in high-risk adults with Type 2 diabetes.
The approval broadens the therapeutic profile of Mounjaro, giving patients and physicians another GLP-1 medication option specifically targeting cardiovascular risk reduction.
Novo Nordisk’s anti-obesity drug Wegovy received a similar FDA approval in 2024, cleared to lower the risk of cardiovascular events in overweight or obese adults who do not have diabetes.
Mounjaro targets both the GIP and GLP-1 hormone receptors and is also prescribed for weight loss under the brand name Zepbound.
Lilly said the new cardiovascular approval followed a large clinical study that compared Mounjaro directly against the company’s older diabetes drug, Trulicity.
Results from that trial showed Mounjaro outperformed Trulicity, with patients on Mounjaro experiencing an 8% lower rate of cardiovascular death, heart attack, or stroke.
The GLP-1 drug class continues to expand rapidly, with Lilly, Novo Nordisk, and other drugmakers studying these medications for a growing range of conditions beyond diabetes and obesity.
Lilly’s experimental next-generation weight-loss drug retatrutide showed patients achieved weight loss of 19% to 28% in a recent study, results the company said were comparable to weight-loss surgery for some participants.
Retatrutide works differently from existing medications because it mimics three hormones, acting as a GIP, GLP-1, and glucagon triple hormone receptor agonist.
Wells Fargo recently reported that the pipeline of GLP-1 weight-loss medications now surpasses cancer drugs as the most valuable category of products in pharmaceutical development.
Goldman Sachs projects global sales of weight-loss medications will reach approximately $105 billion by 2030, underscoring the enormous commercial stakes driving investment across the sector.
Medicare has begun covering GLP-1 drugs for older adults under a bridge program, though employer and insurer resistance to covering the medications for weight loss purposes is growing.
Starbucks announced it would no longer cover the cost of GLP-1 weight-loss medications for employees beginning in October, reflecting a broader trend of cost-conscious coverage decisions.
A survey by benefits consultant Mercer found approximately 6% of large employers expect to drop GLP-1 weight-loss drug coverage in 2026, with an additional 5% planning to follow in 2027.
Insurers remain considerably more willing to cover GLP-1 drugs when they are prescribed for Type 2 diabetes, sleep apnea, or cardiovascular risk reduction, meaning Mounjaro’s new approval could meaningfully improve patient access.
