The MHRA has conditionally approved Novo Nordisk’s Wegovy (semaglutide) for adults with metabolic-associated steatohepatitis (MASH) and moderate-to-advanced liver fibrosis, expanding its use into chronic liver disease while additional confirmatory data are generated.
Written By: Nalam Karthik, PharmD
Reviewed By: Pharmacally Editorial Team
The UK Medicines and Healthcare products Regulatory Agency has conditionally approved Wegovy (semaglutide) for the treatment of metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis. Granted on July 3, 2026, the authorization makes semaglutide one of the first GLP-1 receptor agonists approved in the UK for this progressive liver disease, while requiring additional confirmatory evidence from an ongoing clinical study before full marketing authorization can be considered.
The approval broadens semaglutide’s clinical role beyond its existing indications for chronic weight management in adults and adolescents and reduction of major cardiovascular events in adults with obesity or overweight and established cardiovascular disease.
Semaglutide Targets the Metabolic Drivers of MASH
MASH is an advanced form of metabolic dysfunction-associated steatotic liver disease (MASLD), characterized by fat accumulation in the liver accompanied by inflammation and progressive fibrosis. Left untreated, the disease can progress to cirrhosis, liver failure, or hepatocellular carcinoma. Individuals with obesity, type 2 diabetes, dyslipidemia, or other metabolic disorders are at substantially higher risk.
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist administered as a once-weekly subcutaneous injection alongside diet and exercise. By mimicking endogenous GLP-1, it suppresses appetite, increases satiety, and supports sustained weight loss while improving metabolic parameters that contribute to liver inflammation and fibrosis.
Approval Includes Dose Escalation and Post-Marketing Evidence Requirements
Treatment begins with 0.25 mg once weekly, followed by gradual dose escalation every four weeks through 0.5 mg, 1 mg, and 1.7 mg, reaching the standard maintenance dose of 2.4 mg weekly. For patients with obesity and a body mass index (BMI) above 30 kg/m², the dose may be increased to 7.2 mg once weekly after at least four weeks on the 2.4 mg maintenance dose.
The MHRA granted conditional marketing authorization, indicating that available clinical evidence supports a positive benefit-risk profile while acknowledging that additional efficacy and safety data remain necessary. Novo Nordisk must submit results from an ongoing study evaluating semaglutide in adults with MASH and moderate-to-advanced liver fibrosis. The regulator will reassess emerging evidence annually and update prescribing information as appropriate.
MHRA Highlights Favorable Benefit-Risk Profile
Julian Beach, Executive Director of Healthcare Quality and Access at the MHRA, said the available evidence supports semaglutide as a safe and effective treatment option for patients with MASH. He emphasized that, like all GLP-1 receptor agonists, Wegovy is a prescription-only medicine that should be used under medical supervision.
The most frequently reported adverse events remain gastrointestinal, including nausea, diarrhea, constipation, and vomiting, consistent with the established safety profile of the GLP-1 receptor agonist class.
NHS Access Depends on NICE Appraisal
Although MHRA authorization permits marketing of Wegovy for MASH in the UK, patients are not yet eligible for NHS-funded treatment for this indication. Routine NHS availability will depend on a positive recommendation from the National Institute for Health and Care Excellence (NICE), which is currently evaluating the drug’s clinical effectiveness and cost-effectiveness for MASH.
The approval represents an important regulatory milestone in a therapeutic area with limited pharmacological treatment options and reflects growing interest in GLP-1 receptor agonists as therapies capable of addressing the metabolic mechanisms underlying progressive liver disease.
Reference
Semaglutide (Wegovy) approved to treat form of liver disease – GOV.UK
About the Writer
Nalam Karthik (LinkedIn) is a healthcare writer and PharmD graduate with interests in pharmacovigilance, drug safety, clinical data analysis, and quality assurance. He is passionate about translating clinical and pharmaceutical knowledge into accessible healthcare content while staying engaged with advancements in drug development and patient safety initiatives.