FDA Approves Resmetirom: The First Treatment for NASH With Liver Fibrosis

15 Mar 2024 • The U.S. FDA has granted accelerated approval to resmetirom as the first treatment for adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis, to be used along with diet and exercise.

Resmetirom is a partial activator of a thyroid hormone receptor; activation of this receptor in the liver reduces liver fat accumulation.

At the 12-month follow-up of a key trial, a greater proportion of subjects who were treated with resmetirom (dose range: 80-100mg) achieved NASH resolution or an improvement in liver fibrosis vs. placebo.

The most common side effects included diarrhea and nausea. The drug comes with certain warnings and precautions, such as drug-induced liver toxicity and gallbladder-related side effects.

Source: FDA | Read full story

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