From Diet Pill to Liver Disease Treatment
Novo Nordisk's Wegovy has received accelerated approval from the US FDA as a treatment for Metabolic Associated Steatohepatitis (MASH). Originally a obesity treatment GLP-1 class drug, it is now emerging as a 'game changer' targeting metabolic diseases overall.
Wegovy Clinical Results
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Obesity Drug Wegovy Approved by FDA as Liver Disease Treatment
Glucagon-like peptide-1 (GLP-1) class drugs, which began as obesity treatments, are now establishing themselves as 'game changers' targeting a broad range of metabolic diseases. Novo Nordisk's obesity treatment 'Wegovy' recently received accelerated approval from the US Food and Drug Administration (FDA) as a treatment for Metabolic Associated Steatohepatitis (MASH), marking a significant expansion of obesity drug indications into cardiovascular, diabetes, and liver diseases.
MASH (Metabolic Associated Steatohepatitis)
This is a condition in which neutral fat accumulates in liver cells even without alcohol consumption. As a serious, progressive metabolic disease affecting the liver, it can be fatal if not properly managed. In the United States, approximately 15 million people are estimated to have MASH, while in Korea, the number is around 400,000. However, due to the lack of effective treatments, it has been called an 'untapped blue ocean.' According to market research firm Data Mint Research, the MASH treatment market, valued at about $7.8 billion (10 trillion won) last year, is expected to grow to $31.8 billion (about 41 trillion won) by 2033. With this approval of Wegovy, the market is likely to develop even more rapidly.
According to industry sources on August 22, the FDA recently approved Wegovy as a treatment for patients with non-cirrhotic MASH. With this additional approval, Wegovy can now be used to treat adult patients with moderate to severe liver fibrosis (stages F2 to F3). In the phase 3 clinical trial that supported this approval, 62.9% of patients in the Wegovy group saw resolution of steatohepatitis, and 36.8% experienced improvement in liver fibrosis. In comparison, the placebo group showed rates of 34.3% and 22.4%, respectively, highlighting a clear difference in effectiveness.
From Diabetes to Obesity to Liver Disease... Expanding the GLP-1 Horizon
GLP-1 class drugs like Wegovy were originally developed as treatments for type 2 diabetes. The GLP-1 hormone is secreted by the gut and acts on the brain's appetite center to reduce food intake. Reduced consumption leads to weight loss, which in turn decreases fat accumulation in the liver (fatty liver). This is a key mechanism for alleviating steatohepatitis and fibrosis. By reducing weight with obesity drugs, liver function improves and MASH can also be treated. With this MASH approval, GLP-1 class obesity treatments have secured an expansion pathway from diabetes to obesity to liver disease.
Eli Lilly, the developer of Mounjaro, is also pursuing the development of its GLP-1 class obesity drug 'Zepbound' as a MASH treatment by expanding its indications. If this drug is approved, competition in the MASH treatment market is expected to intensify further.
Domestic pharmaceutical companies are also making rapid inroads into the MASH field. Hanmi Pharmaceutical has leveraged its experience in developing new drugs for obesity and diabetes to establish a MASH pipeline, while Dong-A ST's subsidiary Metavia has completed phase 2a clinical trials for its MASH treatment candidate 'DA-1241.' Preclinical studies have shown improvements in fatty liver and liver fibrosis. D&D Pharmatech is conducting global clinical trials by expanding its original Alzheimer's drug candidate to include MASH as an indication. Olix is also developing an RNA interference (RNAi)-based therapy targeting MASH.
