Madrigal's drug wins first US approval for fatty liver disease NASH as rivals circle

London: Madrigal Pharmaceuticals' drug became the first to win regulatory approval to treat a serious type of fatty liver disease formerly known as non-alcoholic steatohepatitis (NASH) as the race to tap a multi-billion dollar market intensifies. The approval on Thursday follows limited success to develop a treatment for the disease, which is closely tied to obesity and is spreading fast.

The following companies are also developing treatments for NASH, formally known as metabolic dysfunction-associated steatohepatitis: Company Drug name / Further Recent updates developmental plans stage Akero Efruxifermin Drug

The drug Therapeutics (Mid-stage) tested in significantly two ongoing reduced scarring late-stage after nearly two studies and years in the a separate mid-stage study, mid-stage data showed in study March Altimmune Pemvidutide Mid-stage Drug, in (Mid-stage) trial data December 2022, for the achieved more drug than 75 per cent expected in reduction in first liver fat quarter of content, 2025 compared to placebo in an early-stage trial Boehringer Survodutide

Full trial Trial data from Ingelheim (Mid-stage) data to be February showed and presented significant Zealand Pharma in coming improvement in months liver inflammation and damage without worsening fibrosis or scarring Eli Lilly Tirzepatide - The drug helped (Mid-stage) up to 74 per cent of patients achieve "absence of the disease" at 52 weeks, compared to 13 per cent of patients on placebo Ionis ION224

Trial data Pharmaceuticals (Mid-stage) published in Inc March showed significant improvement in liver inflammation and damage without worsening fibrosis or scarring Merck & Co Efinopegdutide - Mid-stage trial (Mid-stage) data from June showed that efinopegdutide significantly reduced liver fat in patients compared to semaglutide

Novo Nordisk Semaglutide Late-stage No data (Late-stage) study expected to enroll about 1,200 patients Viking VK2809 Additional The drug, in Therapeutics (Mid-stage) data from May, helped the study significantly to be reduce liver fat presented in patients in the first half of 2024 89bio Pegozafermin Company Began first (Late-stage) expects to late-stage study begin for the drug on second Wednesday, which late-stage is intended to trial in support a filing MASH for accelerated patients in approval in the the second U.S. quarter of 2024

(Reporting by Pratik Jain and Mariam Sunny in Bengaluru; Editing by Sriraj Kalluvila and Shounak Dasgupta)