Rezdiffra Authorised by MHRA for Adults with MASH and Moderate to Advanced Liver Fibrosis – Madrigal Pharmaceuticals

The MHRA has authorised the medicine resmetirom (Rezdiffra) to treat adult patients with metabolic dysfunction-associated steatohepatitis (MASH).

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, resmetirom increases fat breakdown. This reduces the amount of fat stored in the liver which can help reduce inflammation, fibrosis, and improve its function.

The authorisations, of resmetirom 60 mg, 80 mg and 100 mg film-coated tablets, were approved under the International Recognition Procedure (IRP).

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

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

Resmetirom is 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.