Danish pharmaceutical corporation Novo Nordisk's obesity treatment Wegovy has succeeded in expanding its indication as a treatment for the liver disease 'metabolic dysfunction-associated steatohepatitis (MASH).'
The indication, simply put, is the range of permitted treatments. As the indication expands, the patient population eligible for the prescription of that medication also increases. For pharmaceutical companies, this translates to a larger market, which is interpreted positively.
The U.S. Food and Drug Administration (FDA) announced that on the 15th, Wegovy was granted accelerated approval as a treatment for adult MASH patients with moderate to severe liver fibrosis.
MASH is a progressive liver disease characterized by inflammation and damage, leading to fibrosis in the liver. It is estimated that there are about 440 million patients worldwide, and about 5% of U.S. adults are affected.
With this approval, Wegovy becomes the first treatment among glucagon-like peptide (GLP)-1 mimic drugs to receive approval for treating MASH. The GLP-1 hormone is secreted in the intestines after meals, increasing insulin production in the pancreas, lowering blood sugar, and inducing a feeling of fullness in the brain.
Obesity treatments available on the market, including Wegovy, were originally approved for diabetes treatment and have since proven weight loss effects, leading to an expansion of their indications as obesity treatments.
Previously, the only MASH treatment approved by the FDA was Rezdiffra, from U.S. biopharmaceutical company Madrigal Pharmaceuticals, which received approval last year.
Jason Brett, U.S. medical head of Novo Nordisk, said, 'There have been very few effective treatments in this area,' and noted, 'Wegovy has become the second FDA-approved treatment for MASH.' He added, 'Access to treatment in the early stages of the disease is crucial,' and stated, 'We will do our best to improve accessibility and coverage in cooperation with insurance companies.'
However, Novo Nordisk advised that MASH patients should use Wegovy in conjunction with a proper diet and exercise.
The FDA's accelerated approval is a system designed to quickly supply treatments for serious diseases to the market. It provides conditional approval, prompting additional evidence of effectiveness through follow-up trials.
This decision was based on the results of Phase 1 of a 2-phase study that Novo Nordisk is conducting. In the study, Wegovy showed efficacy in improving liver conditions in patients with MASH and liver fibrosis compared to a placebo. Phase 2 results are expected to be released in 2029. The FDA plans to confirm actual clinical efficacy through final clinical results.
Meanwhile, American Eli Lilly, domestic Hanmi Pharmaceutical, and D&D Pharmatech, among other domestic and international pharmaceutical companies, are also developing treatments for metabolic diseases, including MASH.
☞ MASH (Metabolic dysfunction-Associated Steatohepatitis)
Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease associated with metabolic disorders such as obesity, diabetes, and hypertension. Metabolism is the process by which the body breaks down nutrients to obtain energy and expel waste products. This condition is more severe than simple fatty liver, as inflammation and fibrosis occur in the liver, which can lead to cirrhosis and liver cancer if left untreated. While it is common with about 5% of U.S. adults affected, there have been few effective treatments until now. Previously known as NASH (non-alcoholic steatohepatitis), the name MASH was agreed upon last year by the International Liver Association to emphasize metabolic factors.