Rezdiffra – A new treatment for noncirrhotic non-alcoholic steatohepatitis (NASH)

September 5, 2024
Employee Health & Benefits, Pharmacy

Rezdiffra (resmetirom) is a newly approved (March 14, 2024) medication for the treatment of noncirrhotic non-alcoholic steatohepatitis (NASH), a form of fatty liver disease. It is manufactured by Madrigal Pharmaceuticals and has been granted accelerated approval by the U.S. Food and Drug Administration (FDA).¹ Rezdiffra is an oral pill that acts as a thyroid hormone receptor (THR)-beta agonist, reducing liver fat accumulation and improving liver health.

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Prior to the availability of this new drug therapy, NASH was treated primarily through lifestyle modifications and managing underlying risk factors. These included maintaining a healthy diet, exercising regularly, managing blood pressure, cholesterol and diabetes, as well as avoiding alcohol and medications that may be harmful to the liver.

The mechanism of action of Rezdiffra involves activating the THR-beta receptor, which helps to regulate lipid metabolism, reduce triglyceride levels, and reduce liver fat.² By targeting this receptor, Rezdiffra aims to resolve NASH without worsening fibrosis, a common complication of the disease.

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Clinical trials and side effects

Clinical trials have shown promising results for Rezdiffra. In an ongoing Phase III trial, the medication was tested at two dose strengths. At the lower dose, Rezdiffra resolved NASH without worsening fibrosis in 26% of patients, while at the higher dose, this rate increased to 30%.² Additionally, in the Phase 3 MAESTRO-NASH biopsy trial, 80% of patients treated with a dosage of Rezdiffra 100 mg experienced improvement or stabilization of fibrosis.³

The most common side effects associated with Rezdiffra, affecting at least 5% of patients, include diarrhea, itching, constipation, nausea, vomiting, and stomach pain. The medication can also be toxic to the liver and requires monitoring for liver injury.¹

Rezdiffra should be used in conjunction with a healthy diet and exercise regimen. It is indicated for adults with moderate to advanced liver scarring (fibrosis) due to NASH, but not for those with cirrhosis of the liver.

How can Marsh McLennan Agency Help?

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