Mounjaro wins US approval to cut heart attack and stroke risk - Share Talk

Mounjaro wins US approval to cut heart attack and stroke risk

MedPal AI plc (AIM: MPAL) has highlighted the potential expansion of the GLP-1 market after the US Food and Drug Administration approved Eli Lilly’s Mounjaro to reduce the risk of major cardiovascular events in adults with type 2 diabetes who are at high risk.

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The new US indication covers cardiovascular death, heart attack and stroke, moving Mounjaro beyond its established role in diabetes and weight management and into cardiovascular risk reduction.

MedPal believes the development could substantially increase the addressable market for GLP-1 medicines. Eli Lilly estimates that as many as one in three US adults with type 2 diabetes has undetected cardiovascular disease.

Applying the same proportion to the UK, where more than 4.7 million people have diagnosed diabetes and around 90% have type 2, MedPal estimates that approximately 1.4 million UK adults could fall within a comparable high cardiovascular-risk population.

The FDA decision follows results from the SURPASS-CVOT trial, which followed 13,299 patients for approximately five years. Eli Lilly reported an 8% lower rate of cardiovascular death, heart attack or stroke with Mounjaro compared with Trulicity, another GLP-1 treatment with established cardiovascular benefit.

European regulators added the cardiovascular outcome data to Mounjaro’s EU product information in June. However, MedPal stressed that no equivalent UK label change has been announced, and the US approval does not alter how Mounjaro can currently be prescribed in Britain.

The announcement comes as MedPal scales its New Health private prescription business. The company said Eli Lilly’s once-daily oral GLP-1 weight-loss treatment Foundayo is now available through New Health following its UK authorisation in August.

New Health generated more than £180,000 of private prescription revenue during July, following approximately three weeks of marketing. MedPal said this represented an annualised run rate exceeding £2.2 million, compared with an overall group annualised recurring revenue run rate of approximately £8.6 million.

MedPal argues that cardiovascular indications could further broaden long-term demand for GLP-1 therapies beyond diabetes and obesity. The company cited external forecasts suggesting the global GLP-1 market could reach approximately £140 billion by 2035.

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.”


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