USA—Rezdiffra has been approved by the Food and Drug Administration, marking a significant breakthrough in the treatment of metabolic dysfunction-associated steatohepatitis (MASH), a prevalent liver condition targeted by drugmakers over the last decade.

Developed by biotechnology company Madrigal Pharmaceuticals, Rezdiffra is the first treatment approved for individuals with MASH and moderate to advanced liver fibrosis, in addition to diet and exercise.

The approval follows an ongoing experiment that demonstrated the drug’s efficacy in clearing MASH and reducing liver scarring associated with the disorder.

MASH commonly coexists with metabolic illnesses such as diabetes and obesity, characterized by fat buildup in the liver leading to inflammation and scarring.

It has emerged as one of the leading causes of liver transplantation.

Rezdiffra functions by activating a type of thyroid hormone crucial for liver function but ineffective in MASH, aiming to reverse fat buildup and liver impairment.

The Phase 3 results, published in The New England Journal of Medicine, showcased the medication’s success in meeting its trial objectives of alleviating symptoms and reducing liver fibrosis without exacerbating the condition.

Additionally, Rezdiffra showed promise in reducing signs of heart disease.

While common adverse effects included diarrhea, nausea, and vomiting, the relevance of the observed increase in sex hormones during long-term use remains uncertain.

Prof. Kenneth Cusi, from the University of Florida, lauded the findings, suggesting they should influence guideline recommendations for primary care physicians to assess individuals at high risk of MASH.

Nikolay Nikolov, interim director of the FDA’s unit reviewing immunology and inflammation therapies, emphasized the significance of Rezdiffra’s approval, providing patients with a therapy alternative beyond diet and exercise for the first time.

However, challenges lie ahead for Madrigal and other players in the field, as the sales potential for MASH medications remains uncertain.

Eli Lilly’s Zepbound and Boehringer and Zealand Pharma’s Survodutide have shown promising early research results, posing competition to Rezdiffra.

Additionally, a medication by Akero Therapeutics, currently in late-stage development, may have a greater impact on liver scarring, potentially challenging Rezdiffra’s position in the market.

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