New Hope for Fatty Liver: Tackling Scarring Head-On

The European Medicines Agency (EMA) has suggested granting provisional marketing authorization for Rezdiffra (resmetirom) the first treatment in the EU for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with modest to advanced liver fibrosis, in conjunction with diet and exercise.

MASH is a serious liver condition caused by fat buildup that leads to inflammation and fibrosis, potentially progressing to cirrhosis or liver cancer. Until now, there were no approved treatments for MASH in Europe.

Rezdiffra works by activating a thyroid hormone receptor (THR‑β) in the liver, reducing fat accumulation, inflammation, and scarring. In a pivotal clinical trial involving over 900 patients, Rezdiffra showed promising results:

• Up to 30% achieved MASH resolution without worsening fibrosis.
• Up to 29% showed improvement in fibrosis without worsening MASH.

The most common side effects reported were diarrhea, nausea, and itching.

As this is a conditional approval, ongoing studies are required to confirm long-term efficacy and safety. Final authorization will be granted by the European Commission, with pricing and reimbursement to be determined by each EU country.

Learn more: First treatment against liver scarring caused by a type of ‘fatty liver disease’ | European Medicines Agency (EMA)