The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) has announced new guidance allowing the weight-loss drug semaglutide, sold as Wegovy, to be prescribed for adults with metabolic-associated steatohepatitis (MASH), a serious form of fatty liver disease. MASH occurs when excess fat accumulation in the liver leads to inflammation and scarring, often affecting individuals with obesity, type 2 diabetes, or high blood fat levels.
The approval permits the prescription of semaglutide for adults with MASH who have moderate to advanced liver fibrosis. Julian Beach, Executive Director of Healthcare Quality and Access at the MHRA, stated that the available evidence supports semaglutide as a safe and effective treatment option for MASH patients. He emphasized that, like other GLP-1 receptor agonists, it is a prescription-only medication requiring consultation with a doctor.
Currently, semaglutide is not available on the National Health Service (NHS) specifically for treating MASH. Patients will need to obtain a private prescription while the National Institute for Health and Care Excellence (NICE) assesses the drug's clinical and cost-effectiveness for routine NHS provision. The MHRA's approval is conditional, pending further results from an ongoing study on adults with MASH and significant liver scarring, before full marketing authorization is granted.
Semaglutide functions as a GLP-1 receptor agonist, mimicking a hormone that promotes satiety, reduces cravings, and aids weight loss. It is administered alongside diet and exercise. The medication is already authorized for weight management in adults and adolescents and for reducing cardiovascular event risk in adults. Treatment typically begins with a low weekly dose, gradually increasing to a maintenance dose of 2.4mg, with potential increases for patients with obesity.
The MHRA will conduct annual reviews of semaglutide and update product information as necessary, continuing to monitor its safety and effectiveness. Common side effects include gastrointestinal issues such as nausea, diarrhea, constipation, and vomiting, with patients advised to report any suspected side effects to healthcare professionals.
Fatty liver disease, now a rapidly growing global health concern, is a leading cause of death in the UK. While often associated with alcohol, experts note that obesity, diabetes, and poor diet are increasingly contributing to its rise, putting millions of non-drinkers at risk. The condition can develop silently, with significant, sometimes irreversible, damage occurring before symptoms appear, potentially leading to cirrhosis, liver failure, or cancer.
This development follows the recent availability of a tablet form of semaglutide in the UK, with one pharmacy chain offering it for as little as £79 per month. The weekly injection form typically costs between £80 and £140 per month for the lowest dose. The new daily tablet has shown slightly less effectiveness in weight loss compared to the injections, with trial patients losing around 17% of their body weight after 64 weeks on the highest dose.