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UK MHRA Approves Wegovy for Treatment of MASH in Adults with Liver Fibrosis

UK MHRA Approves Wegovy for Treatment of MASH in Adults with Liver Fibrosis

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorisation for Novo Nordisk's Wegovy (semaglutide) to treat Metabolic-Associated Steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis, expanding the medicine's therapeutic indications beyond obesity and cardiovascular risk reduction.

The approval, granted on July 3, 2026, makes semaglutide one of the latest therapies to receive regulatory backing for MASH, a progressive liver disease characterised by fat accumulation, inflammation and scarring that can lead to severe liver damage if left untreated.

MASH commonly develops in individuals with obesity, type 2 diabetes or elevated blood lipid levels, making it an increasingly significant public health concern worldwide.

According to the MHRA, available clinical evidence demonstrates that semaglutide is a safe and effective treatment option for eligible patients. However, the regulator emphasised that the medicine remains prescription-only and should be used under the supervision of a healthcare professional.

Julian Beach, Executive Director of Healthcare Quality and Access at the MHRA, said the current evidence supports semaglutide as an effective therapeutic option for patients with MASH while reiterating that treatment decisions should be made in consultation with a doctor.

The recommended dosing regimen begins with 0.25 mg administered once weekly, with gradual dose escalation to 0.5 mg, 1 mg and 1.7 mg at four-week intervals before reaching the standard maintenance dose of 2.4 mg once weekly. For patients with obesity, defined as a Body Mass Index (BMI) above 30, the dosage may be increased to 7.2 mg once weekly after at least four weeks on the 2.4 mg maintenance dose.

The authorisation has been issued on a conditional basis, requiring Novo Nordisk to submit additional data from an ongoing clinical study evaluating semaglutide in adults with MASH and moderate-to-advanced liver fibrosis. The MHRA said further confirmatory evidence on the medicine's efficacy and safety will be required before a full marketing authorisation can be granted.

The regulator will continue to review new clinical and safety data annually and update the product information whenever necessary.

Despite the regulatory approval, patients in the UK are not yet able to access semaglutide for MASH treatment through the National Health Service (NHS). Availability under the NHS will depend on a recommendation from the National Institute for Health and Care Excellence (NICE), which is currently assessing the medicine's clinical and cost effectiveness for this indication.

Semaglutide is a GLP-1 receptor agonist prescribed alongside diet and exercise. The therapy mimics the naturally occurring glucagon-like peptide-1 hormone released after meals, helping regulate appetite by increasing feelings of fullness and reducing food intake.

The MHRA said it will continue monitoring the medicine's safety profile. The most frequently reported adverse effects include gastrointestinal symptoms such as nausea, diarrhoea, constipation and vomiting. Healthcare professionals and patients are encouraged to report suspected side effects through the agency's Yellow Card safety monitoring programme.

The approval represents another milestone for semaglutide, which already holds UK authorisations for chronic weight management in adults and adolescents, as well as for reducing the risk of major cardiovascular events in adults.

More news about: quality / gmp | Published by News Bureau | July - 06 - 2026

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