The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for a semaglutide injection, marketed as Wegovy, to treat metabolic-associated steatohepatitis (MASH) in adults who exhibit moderate to advanced liver fibrosis. This decision was announced on 3 July 2026.
Semaglutide already holds authorisations for weight management in both adults and adolescents, as well as for reducing the risk of cardiovascular events in adults. The condition MASH arises when an accumulation of fat in the liver leads to inflammation and scarring, with individuals who are obese, have type 2 diabetes, or exhibit elevated blood lipid levels being at a higher risk of developing the condition.
Expert Insights on Semaglutide’s Approval
Julian Beach, the Executive Director of Healthcare Quality and Access at the MHRA, commented on the new treatment option, stating: “The available evidence indicates that semaglutide is a safe and effective treatment option for patients with MASH. As with all GLP-1 receptor agonists, this is a prescription-only medication and should only be taken in consultation with a doctor.”
The treatment regimen begins with an initial dose of 0.25 mg of semaglutide administered weekly. This dosage is gradually increased to 0.5 mg, 1 mg, and then 1.7 mg, with each dose being maintained for four weeks, ultimately reaching a maintenance dose of 2.4 mg weekly. For patients with obesity, characterised by a BMI over 30, the dosage may be escalated to 7.2 mg weekly after at least four weeks on the 2.4 mg dose.
Conditional Marketing Authorisation Details
The approval for semaglutide to treat MASH comes with the stipulation that further results from a currently ongoing study involving adults with MASH and moderate to advanced liver scarring must be submitted. This conditional marketing authorisation indicates that additional confirmatory evidence regarding its efficacy and safety as a treatment for MASH is required before a full marketing authorisation can be obtained.
The MHRA has committed to reviewing new information regarding this medication at least annually, with updates to the Summary of Product Characteristics being made as necessary.
Access to Treatment and Ongoing Evaluations
At present, patients diagnosed with MASH cannot access semaglutide through the NHS. The National Institute for Health and Care Excellence (NICE) is currently evaluating its clinical and cost-effectiveness as a treatment option for this condition, which will determine future accessibility.
Semaglutide operates as a GLP-1 receptor agonist and is intended to be used in conjunction with a balanced diet and exercise programme. It functions by imitating the actions of glucagon-like peptide (GLP-1), a hormone naturally released after eating, which aids in prolonging feelings of fullness and curbing food cravings.
Monitoring Safety and Side Effects
The MHRA maintains vigilant oversight of the safety and efficacy of semaglutide. Common side effects associated with the medication include gastrointestinal disorders such as nausea, diarrhoea, constipation, and vomiting. Patients experiencing any adverse effects are advised to consult with their healthcare provider and report these occurrences through the Yellow Card scheme, which can be accessed via their website or mobile applications available on both Google Play and Apple App stores.
Additional Information for Stakeholders
The authorisation for this new application of semaglutide (Wegovy) was officially granted to Novo Nordisk on 3 July 2026. Comprehensive information regarding the medication will be made available in the Summary of Product Characteristics and Patient Information leaflets, which are expected to be published on the MHRA Products website within seven days of the approval.
The MHRA serves as the regulatory body overseeing all medicines and medical devices within the UK, ensuring their efficacy and safety. Their operations are grounded in meticulous, evidence-based assessments to ensure that the benefits of treatments outweigh any associated risks. The MHRA operates as an executive agency under the Department of Health and Social Care.
For media inquiries, please reach out to the news centre via telephone at 020 3080 7651 or email at newscentre@mhra.gov.uk.
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