Rezdiffra authorised in the UK for adults with MASH and moderate-to-advanced liver scarring

Madrigal Pharmaceuticals/Rezdiffra

The UK medicines regulator (MHRA) authorised Madrigal's Rezdiffra (resmetirom) on 3 June 2026 for adults with MASH and stage 2 or 3 liver fibrosis. It used the International Recognition Procedure, which relies on the earlier EU decision. The approval does not settle NHS funding, which still has to be negotiated.

• Authorised strengths: 60 mg, 80 mg and 100 mg oral tablets; the basis is the EU conditional approval of August 2025.
• The main study enrolled 917 adults with MASH and moderate or advanced fibrosis and ran 12 months against placebo.
• MASH resolution with no fibrosis worsening: about 26–30% on resmetirom vs 10% on placebo, depending on dose.
• Fibrosis improvement with no MASH worsening: 27–29% on resmetirom vs 17% on placebo.
• Approval is not reimbursement: NHS coverage requires separate negotiation, not yet reported.