MHRA authorises resmetirom (Rezdiffra) for treating adult MASH

The Medicines and Healthcare products Regulatory Agency (MHRA) announced on 3 June 2026 that resmetirom (brand name Rezdiffra) has been authorised for the treatment of adult patients with metabolic dysfunction‑associated steatohepatitis (MASH). The drug is approved for use in adults who have moderate or advanced liver fibrosis (stage 2or 3). Resmetirom activates thyroid hormone receptor‑β in hepatocytes, increasing fat breakdown and reducing liver fat, inflammation and fibrosis. The approval covers 60 mg, 80 mg and 100 mg film‑coated tablets and was granted under the International Recognition Procedure. In a 12‑month study, 26–30 % of patients receiving resmetirom achieved MASH resolution versus 10 % on placebo, and 27–29 % improved fibrosis versus 17 % on placebo. Common side effects include diarrhoea and nausea. Patients experiencing side effects are advised to contact their doctor or report to the MHRA Yellow Card scheme.

© Crown copyright, 2024, GOV.UK.
Summary adapted from content licensed under the Open Government Licence v3.0.
For details, see https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/.
Original source: https://www.gov.uk/

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