In Korea, Wegovy is expected to become available for prescription to patients with metabolic dysfunction–associated steatohepatitis (MASH), commonly called "fatty liver." Wegovy is currently prescribed for obesity and cardiovascular patients, and going forward, patients with excessive fat accumulation in the liver may also be able to receive treatment.
According to the pharmaceutical industry on the 22nd, Korea Novo Nordisk Pharma has applied to the Ministery of Food and Drug Safety to expand Wegovy's indication so it can be prescribed to patients with metabolic dysfunction–associated steatohepatitis. It is reportedly under review by the regulator. If it is proven that Wegovy can be used safely by patients with metabolic dysfunction–associated steatohepatitis, it can receive approval from the Ministery of Food and Drug Safety.
Wegovy was approved by the U.S. Food and Drug Administration (FDA) as a treatment for metabolic dysfunction–associated steatohepatitis in Aug. last year. Korea Novo Nordisk Pharma is said to have submitted the same clinical data to the Ministery of Food and Drug Safety as it submitted to the FDA. A pharmaceutical industry official said, "Since the same data was used to obtain approval for the expanded indication in the United States, there is a chance it will be approved domestically as well." The Ministery of Food and Drug Safety said it was difficult to comment.
Wegovy is an obesity treatment that mimics the glucagon-like peptide (GLP)-1 hormone. GLP-1 is secreted from the small intestine after meals and promotes insulin secretion from the pancreas to lower blood sugar. It was originally developed as a diabetes treatment, then evolved into an obesity therapy after its weight-loss effects were confirmed. It works by reducing appetite in the brain and slowing the rate at which food leaves the stomach to increase satiety.
In Korea, Wegovy can be prescribed to adult patients with obesity who have a body mass index (BMI) of 30 or higher, or to patients with a BMI of 27 or higher who also have cardiovascular disease. For adolescents age 12 and older, it can be prescribed if body weight is at least 60 kg. If the Ministery of Food and Drug Safety approves the expanded indication for metabolic dysfunction–associated steatohepatitis, the number of eligible patients will increase and the market will expand accordingly.
Metabolic dysfunction–associated steatohepatitis is a condition in which fat accumulates in the liver and causes inflammation. It can lead to hepatitis, cirrhosis, and liver cancer, and it can occur even without drinking alcohol. The global number of patients with metabolic dysfunction–associated steatohepatitis is estimated at 400 million. Evaluate Pharma, a pharmaceutical market research firm, projected that the global market for treatments for metabolic dysfunction–associated steatohepatitis will grow from 270 billion won in 2024 to 14 trillion won in 2030.