FDA Approval of Mounjaro for Heart Protection

FDA approves tirzepatide to cut the risk of heart attack and stroke in type 2 diabetes, as Eli Lilly's weight loss pill Foundayo goes live on New Health (new.co.uk)

MedPal AI plc (AIM: MPAL; FRA: Z1N), the AI-native digital health and pharmacy group, notes Eli Lilly's announcement of 28 August 2026 that the US Food and Drug Administration (FDA) has approved Mounjaro (tirzepatide) to lower the risk of major adverse cardiovascular events, including cardiovascular death, heart attack and stroke, in adults with type 2 diabetes who are at high risk of these events.

The Board believes this approval marks the point at which GLP-1 medicines move beyond weight loss and diabetes into the prevention of heart attacks and strokes, dramatically expanding the addressable market for the category in which the Group's dedicated GLP-1 clinic, New Health (new.co.uk), operates.

Highlights

• A dramatically bigger market. Eli Lilly estimates that as many as one in three adults with type 2 diabetes in the US has undetected cardiovascular disease. The new indication opens Mounjaro to this much larger population of patients at high cardiovascular risk, well beyond weight management.
• The UK opportunity is of similar scale. Over 4.7 million people in the UK are diagnosed with diabetes, approximately 90 per cent with type 2 (Diabetes UK, 2024/25). On the same one in three basis, the Board estimates that around 1.4 million UK adults could fall within the population addressed by the new indication.
• Proven in one of the largest GLP-1 trials ever run. SURPASS-CVOT followed 13,299 patients for approximately five years. Eli Lilly reported an 8 per cent lower rate of cardiovascular death, heart attack or stroke for Mounjaro versus Trulicity (dulaglutide), itself a GLP-1 treatment with established cardiovascular benefit.
• Europe is already moving. The European Medicines Agency added the cardiovascular outcome data to Mounjaro's EU product information in June 2026, and Eli Lilly has stated that regulatory submissions based on the trial are under review in additional markets. No equivalent UK label change has been announced, however, and there can be no certainty as to whether or when one will occur.
• Foundayo now live on New Health. Foundayo (orforglipron), Eli Lilly's once daily oral GLP-1 weight loss pill, which was authorised by the MHRA on 10 August 2026 (the UK the first country in Europe to do so), is now available through New Health, which began offering it in the first days of UK commercial supply.
• New Health is scaling into this opportunity. As announced on 4 August 2026, New Health generated over £180,000 of private prescription revenue in July 2026 following only three weeks of marketing. This equates to an annualised run rate of over £2.2 million, within a Group annualised recurring revenue run rate of approximately £8.6 million.

From weight loss to heart health

The Board believes the FDA approval is the clearest signal yet that the GLP-1 category is compounding. These medicines began as a treatment for diabetes, became the fastest growing category in weight management, and are now approved in the US to protect the heart. Each new proven benefit brings a new population of patients into the category and strengthens the case for long term treatment.

Published research already pointed to rapid growth before this approval: Morgan Stanley Research has forecast that the global GLP-1 market could reach approximately £140 billion by 2035, and Grand View Research projects that the UK prescription weight loss medications market will grow from approximately £313 million in 2025 to approximately £1.85 billion by 2033. Mounjaro commands approximately 79 per cent of the UK GLP-1 market, as set out in the Company's announcement of 28 January 2026.

The new US indication does not itself change UK prescribing, and Mounjaro remains available in the UK under its existing authorisation, which New Health already dispenses through the Group's direct arrangements as an authorised purchaser of Eli Lilly products. The Board believes the cardiovascular outcome data will accelerate adoption across the category and, if reflected in the UK label in due course, would further expand the population for whom treatment is clinically relevant.

Chief Executive Officer's Commentary

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."

The Directors of the Company are responsible for the contents of this announcement.