Mounjaro Gets FDA Nod to Reduce Heart Risks in Type 2 Diabetes Patients
Synopsis
The FDA approved Eli Lilly’s Mounjaro for cardiovascular risk reduction in adults with type 2 diabetes at high risk of heart attack or stroke, putting the drug in closer competition with Novo Nordisk’s GLP-1 treatments.
The US FDA approved Mounjaro for treatment of diabetes, adding to its approved indications for treatment of type 2 diabetes for adult patients at high risk of MACE.
The Mounjaro approval, announced on August 28th, includes cardiovascular death, non-fatal heart attack and non-fatal stroke, and the drug was previously approved for treating adult and children over age 10 in controlling blood sugar in type 2 diabetes.
Trial Compared Mounjaro With Trulicity
SURPASS-CVOT is a Phase 3 study that included 13,299 patients from 640 centers in 30 countries, supporting the FDA approval for the Mounjaro drug.
Participants were given either Mounjaro or Trulicity (dulaglutide) another diabetes drug approved for cardiovascular use. Mounjaro was shown to be non-inferior to Trulicity for major cardiovascular events over a median follow-up period of 210.1 weeks.
The study found that the risk of cardiovascular death, heart attack or stroke with Mounjaro was 8% lower compared to Trulicity. The trial "did not prove statistical superiority over the comparator," Lilly said.
Lilly Sales Rise as Diabetes Burden Grows
The Mounjaro FDA clear is a significant triumph for Lilly, as the drug has come to be a big part to its income. The second quarter of 2026 saw Mounjaro realize global revenue of $9.9 billion, a 91% rise compared to the same period a year prior.
US revenue grew 45% to $4.8 billion, while revenue out of the US grew 172% to $5.2 billion. Lilly's second-quarter revenue was $23.0 billion, while the company upped its 2026 revenue prediction to $85 billion-$87 billion.
The overall diabetes market is still large. According to the 11th Edition of the IDF Diabetes Atlas, as of 2024, 589 million adults aged 20–79 are living with diabetes, and this number is expected to reach 853 million by 2050.
In 2024, India ranked second to have the highest number of adults with diabetes at 89.8 million. Australia falls under the IDF Western Pacific region where the greatest number of people with diabetes exists.
Source: Reuters
Pooja Malik is a business journalist with over six years of experience covering startups, entrepreneurship, and emerging trends. She has previously worked with leading media platforms such as YourStory Media and BW BusinessWorld, where she reported on business, policy, and market developments. Currently, she serves as Editor at The Inspirepreneur Magazine, where she writes and edits stories across business, lifestyle, and travel, with a focus on clarity, accuracy, and reader relevance.
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