People living with metabolic dysfunction-associated steatohepatitis (MASH) have received encouraging news, with the UK medicines regulator approving two treatments for the condition within the past month. The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised both resmetirom (Rezdiffra) and semaglutide (Wegovy) for use in adults with MASH and liver fibrosis, marking a significant milestone in the treatment of liver disease. [gov.uk], [gov.uk]
Welcoming the announcements, Vanessa Hebditch, Director of Communications and Policy at the British Liver Trust, said:
“We warmly welcome the approval of both resmetirom and semaglutide for people living with MASH. These decisions represent an important step forward and offer real hope to the growing number of people affected by this serious liver condition.
“For too long, patients have had very few treatment options available to them. The development of medicines that can help tackle the underlying disease is enormously encouraging.
“However, it is important for patients to understand that these treatments will not be routinely available free on the NHS until they have completed the NICE appraisal process and decisions have been made about NHS funding. We look forward to working with decision-makers to ensure people living with MASH can benefit from effective new treatments as quickly as possible.”
MASH is an advanced form of fatty liver disease in which excess fat in the liver leads to inflammation and damage. Over time, this can cause scarring (fibrosis), cirrhosis, liver failure and an increased risk of liver cancer. The condition is closely linked to obesity, type 2 diabetes and other metabolic health conditions. MASLD used to be called NAFLD or fatty liver disease.
In June, the MHRA authorised resmetirom (Rezdiffra) for adults with MASH and moderate-to-advanced fibrosis. It is the first medicine approved in the UK specifically for people with MASH and liver scarring.
Resmetirom works by activating a receptor in the liver that helps increase the breakdown of fat and reduce fat stored in liver cells. This can help reduce inflammation and fibrosis and improve liver function.
The approval was based on a clinical trial involving more than 900 adults with MASH and fibrosis. After 12 months of treatment, approximately 26–30% of people taking resmetirom achieved resolution of MASH without worsening fibrosis, compared with 10% of those taking a placebo. Improvements in liver scarring were also reported in a greater proportion of patients receiving the medicine.
This week, the MHRA approved semaglutide (Wegovy) for adults with MASH and moderate-to-advanced liver fibrosis. Semaglutide is already licensed for weight management and reducing cardiovascular risk, but this is the first time it has been approved in the UK to treat MASH.
Semaglutide belongs to a group of medicines called GLP-1 receptor agonists. It helps people feel fuller for longer and reduces food cravings, supporting weight loss alongside diet and exercise. Weight loss is known to be one of the most effective ways to improve fatty liver disease and MASH.
The MHRA has granted semaglutide a conditional marketing authorisation, meaning further evidence from ongoing clinical studies will be reviewed before a full licence is granted.
What happens next?
While these approvals are significant developments, they do not mean the medicines are immediately available on the NHS for people with MASH.
Before treatments can be routinely prescribed and funded by the NHS, they must be assessed by the National Institute for Health and Care Excellence (NICE), which evaluates both clinical effectiveness and value for money. Both treatments are currently undergoing NICE appraisal for MASH.
For people living with MASH, these approvals signal real progress towards having effective treatments available for a condition that has historically had very few therapeutic options. The British Liver Trust will continue to monitor developments and advocate for timely access to new treatments for patients who may benefit from them.
If you have questions about MASH or fatty liver disease, support and information are available through the British Liver Trust’s nurse-led helpline and information services.