MedPal AI highlights FDA approval of Mounjaro for cardiovascular risk reduction

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MedPal AI plc (LSE:MPAL) noted Eli Lilly’s announcement that the U.S. Food and Drug Administration has approved Mounjaro (tirzepatide) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk of such events.

The approval, announced on August 28, 2026, covers cardiovascular death, heart attack and stroke. MedPal said the expanded indication increases the potential patient population for GLP-1 medicines beyond their existing use in diabetes and weight management.

The company operates New Health, its dedicated GLP-1 weight management clinic, which already dispenses Mounjaro in the UK under the medicine’s existing UK authorisation.

MedPal estimates potential UK population of around 1.4 million

Eli Lilly estimates that as many as one in three U.S. adults with type 2 diabetes has undetected cardiovascular disease, according to MedPal.

In the UK, more than 4.7 million people have been diagnosed with diabetes, approximately 90% of whom have type 2 diabetes, based on Diabetes UK figures for 2024/25.

Applying the same one-in-three assumption, MedPal’s board estimates that approximately 1.4 million UK adults could fall within the population addressed by the new U.S. indication. The FDA decision does not alter Mounjaro’s current UK prescribing authorisation.

The European Medicines Agency added cardiovascular outcome data to Mounjaro’s EU product information in June 2026. Eli Lilly has also said regulatory submissions based on the data are under review in other markets. MedPal noted that no equivalent UK label change has been announced and that there is no certainty over whether or when one will occur.

SURPASS-CVOT included more than 13,000 patients

The FDA decision followed cardiovascular data from the SURPASS-CVOT study, which tracked 13,299 patients for approximately five years.

According to Eli Lilly, the study showed an 8% lower rate of cardiovascular death, heart attack or stroke for Mounjaro compared with Trulicity (dulaglutide), another GLP-1 treatment with an established cardiovascular benefit.

MedPal said the results add cardiovascular risk reduction to the range of applications being considered for GLP-1 medicines.

Morgan Stanley Research has forecast that the global GLP-1 market could reach approximately £140 billion by 2035, while Grand View Research projects the UK prescription weight-loss medication market will increase from approximately £313 million in 2025 to around £1.85 billion by 2033.

MedPal previously stated that Mounjaro accounted for approximately 79% of the UK GLP-1 market as of its January 28, 2026 announcement.

Foundayo available through New Health

MedPal also said Foundayo (orforglipron), Eli Lilly’s once-daily oral GLP-1 weight-loss medicine, is now available through New Health.

The medicine was authorised by the UK Medicines and Healthcare products Regulatory Agency on August 10, 2026, making the UK the first European country to grant approval, according to the company. New Health began offering Foundayo during the first days of UK commercial supply.

MedPal reported on August 4 that New Health generated more than £180,000 in private prescription revenue during July following three weeks of marketing. The company said this represented an annualised run rate of more than £2.2 million, compared with an annualised recurring revenue run rate of approximately £8.6 million for the wider group.

New Health has direct arrangements as an authorised purchaser of Eli Lilly products and already dispenses Mounjaro under its existing UK authorisation.

MedPal assesses potential expansion of GLP-1 applications

MedPal’s board said it believes cardiovascular data could contribute to increased adoption of GLP-1 medicines and that a future UK label expansion, if approved, could increase the population for whom the treatment is clinically relevant.

The company stressed that the new U.S. indication does not itself change how Mounjaro can currently be prescribed in the UK.

Jason Drummond, Founder and Chief Executive Officer of MedPal, commented:

“GLP-1s began as diabetes treatments and became the biggest story in weight loss. Now the FDA has approved Mounjaro to cut the risk of heart attack and stroke. Every time the science widens, the market follows suit and this is the biggest expansion yet.

“New Health was built for exactly this: direct supply from Eli Lilly and Novo Nordisk, clinician-led prescribing, robotic dispensing, and Foundayo already live on new.co.uk within days of first UK supply. The GLP-1 and peptide opportunity keeps compounding and New Health sits in the middle of it. We are just getting started.”

MedPal operates digital health and pharmacy services

MedPal AI operates a vertically integrated digital health and pharmacy business. Its operations include NHS Distance Selling Pharmacy hubs at Sarus Court in Runcorn and Swaffham, the New Health GLP-1 weight management clinic, a B2B care home pharmacy supply operation and eMARx, its electronic medication administration record software for care homes.

The group also operates Juno, an AI health companion built on Anthropic’s Claude. MedPal is seeking to develop a platform connecting prescribing, dispensing, delivery, medication administration and AI-supported patient services.

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