The U.S. Food and Drug Administration has approved Eli Lilly’s blockbuster diabetes medication Mounjaro to reduce the risk of major cardiovascular events in high-risk adults with type 2 diabetes, according to an announcement reported by GuruFocus. The regulatory decision expands the drug’s label to cover cardiovascular death, nonfatal heart attack, and nonfatal stroke, positioning the once-weekly injectable to capture greater market share in the cardiometabolic treatment space.
Clinical Trial Results and Cardiovascular Outcomes
According to GuruFocus reporting, the FDA approval was supported by the SURPASS-CVOT clinical trial, which directly compared Mounjaro against Lilly’s established GLP-1 medication Trulicity. The study enrolled 13,299 patients across 30 countries. Data showed that Mounjaro produced an 8% lower rate of major cardiovascular events, successfully meeting the trial’s primary goal of non-inferiority compared to Trulicity. However, the trial did not establish statistical superiority over Trulicity. Lilly reports that Mounjaro is now the first and only dual GIP and GLP-1 receptor agonist approved specifically to lower cardiovascular risk in this patient population.
Market Performance and Financial Outlook
The label expansion arrives as tirzepatide sales experience rapid growth globally. According to financial figures published by GuruFocus, Mounjaro generated $9.94 billion in second-quarter revenue, representing a 91% increase year over year. Meanwhile, Zepbound, which shares the same active ingredient and is marketed for weight loss, saw sales climb 46% to $4.93 billion. Driven by this momentum, Eli Lilly raised its 2026 revenue outlook to between $85 billion and $87 billion.
For investors, the primary question centers on whether the new cardiovascular indication will translate into wider prescribing patterns and more robust insurance reimbursement. Analysts note that while volume growth remains strong, lower realized prices partially offset gains during the previous quarter. Furthermore, Lilly faces intensifying competition in the cardiometabolic sector from rival drugmaker Novo Nordisk.
International Regulatory Expansion for Orforglipron
In a separate regulatory development reported by GuruFocus, Eli Lilly secured approval from Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) for its once-daily oral weight-loss pill, Foundayo, also known as orforglipron. Authorized on August 10 for weight management and type 2 diabetes, the pill offers patients an alternative to injectable treatments without food or water intake restrictions. Foundayo previously received U.S. clearance on April 1 and generated $98 million in second-quarter sales.
Despite the U.K. authorization, the MHRA indicated that Foundayo is not yet available through the National Health Service. The National Institute for Health and Care Excellence (NICE) must complete its evaluation before the treatment receives broader NHS access and reimbursement, establishing the next critical milestone for the drug’s international commercial rollout.
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