FDA approves first treatment for liver scarring due to fatty liver disease

Betsy Goodfellow | March 15, 2024 | News story | Medical Communications Endocrinology, FDA, fatty liver disease, liver scarring, nash 

The US Food and Drug Administration (FDA) has announced that it has approved Rezdiffra (resmetirom) for the treatment of adult patients with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), for use alongside diet and exercise.

This approval follows an analysis of the safety and efficacy of the drug based on a surrogate endpoint at month 12 in a 54-month, randomised, double-blind, placebo-controlled trial, which measured the extend of liver inflammation and scarring.

At the 12 month mark, liver biopsies demonstrated that a larger proportion of those treated with Rezdiffra achieved NASH resolution or an improvement in liver scarring, compared to those treated with a placebo. Approximately 26-27% of patients on 80mg of the drug and 24-36% of those on 100mg experienced NASH resolution and no worsening of liver scaring, compared to only 9-13% of those in the placebo group.

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Nikolay Nikolov MD, active director of the Office of Immunology and Inflammation at the FDA’s Center for Drug Evaluation and Research, commented: “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage. Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”

Betsy Goodfellow

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