LONDON, June 3 -- The government of the United Kingdom issued the following news:

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (3June 2026) authorisedthe medicineresmetirom(Rezdiffra) to treatadult patients with metabolic dysfunction-associated steatohepatitis (MASH).

MASH is a liver disease where fat builds up in the liver, which can result in inflammation and damage to the liver cells.It isa result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver dysfunction.

Resmetiromis used in adults who have experienced inflammation and cell damage, resulting in moderate scarring, consistent with stage 2 fibrosis, or significant scarring, consistent with stage 3 fibrosis.

In patients with MASH, a protein called thyroid hormone receptor beta (THR-β), in a type of liver cell called hepatocytes, is less activated. The medicine works by binding to and activating THR-β. By activating this protein in the liver,resmetiromincreases fat breakdown. This reduces the amount of fat stored in the liver which can help reduce inflammation, fibrosis,and improve its function.

Theauthorisations, ofresmetirom60 mg, 80 mg and 100 mg film-coated tablets, wereapproved undertheInternational RecognitionProcedure (IRP).

Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said:

"Resmetiromis the first medicine to be approved for patients with MASH and moderate to advanced liver fibrosis.

"We'reassured that theappropriate regulatorystandards for the approval of this medicine have been metand today's decision reflects the MHRA's commitment to ensuring patients can access innovative treatments that make a real difference.

"As with any medicine,wewill continue to monitorthesafety and effectiveness ofresmetiromclosely."

This approval is supported by evidence from a main study involving 917 adults with MASH and moderate or advanced liver fibrosis who received eitherresmetiromor a placebo for 12 months. Depending on the dose, around 26 to 30 per cent of patients receivingresmetiromachieved MASH resolution with no worsening of fibrosis, compared with 10 per cent on placebo. Additionally, 27 to 29 per cent of those receivingresmetiromhad an improvement in liver fibrosis with no worsening of MASH, compared with 17 per cent on placebo.

Resmetiromis taken orally.The most common side effects of the medicine  (which may affect more than 1 in 10 people) includediarrhoea and nausea.

Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to theYellow Card schemewebsiteor by searching the Google Play or Apple App stores for MHRA Yellow Card. 

Notes to editors  

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Thesenew marketingauthorisationsweregranted on 3 June 2026 to Madrigal Pharmaceuticals EU Limited.

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This product wassubmittedand approved via theInternational Recognition Procedure (IRP).

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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on theMHRA Products websitewithin 7 days of approval.  

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Metabolic dysfunction-associated steatohepatitis (MASH)is aresult of the progression of nonalcoholic fatty liver disease. For more information,visit:non-alcoholicfatty liver disease - NHS

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The Medicines and Healthcare products Regulatory Agency (MHRA)is responsible forregulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.  All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.  

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The MHRA is an executive agency of the Department of Health and Social Care.  

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For media enquiries, please contact thenewscentre@mhra.gov.uk, or call on 020 3080 7651.

Disclaimer: Curated by HT Syndication.