The Food and Drug Administration (FDA) has further expanded the U.S. indications of Novo Nordisk’s (NVO) popular weight loss therapy Wegovy, allowing its use against metabolic dysfunction-associated steatohepatitis (MASH), a liver disorder.
The approval marks the market entry of the latest treatment for the disease, previously known as NASH, after the FDA approval of Madrigal Pharmaceuticals’ (MDGL) once-daily oral therapy Rezdiffra for adults with MASH last year.
In a press release late Friday, the Danish drugmaker announced that the FDA granted accelerated approval for its supplemental New Drug Application, authorizing Wegovy (semaglutide 2.4 mg) for adults with MASH and moderate to advanced liver fibrosis.
The approval, based on Novo’s (OTCPK:NONOF) part 1 of the ESSENCE trial, calls for Wegovy use in combination with a reduced-calorie diet and increased physical activity.
The Phase 3 trial, which tested the once-weekly injectable in 800 people with MASH, backed the company’s European regulatory submission for semaglutide in February.
Eli Lilly (LLY), NVO’s rival in the obesity drug market, has already demonstrated the potential of its weight loss therapy tirzepatide in MASH. In 2024, the U.S. drugmaker said the GIP/GLP-1 dual receptor agonist was found to be superior to placebo in the company’s Phase 2 SYNERGY-NASH trial for adults with MASH.
The FDA first approved Wegovy in 2021 for adults with obesity or overweight and later expanded its label in 2022 to children aged 12 years and above with obesity. Last year, the agency approved Wegovy to reduce the risk of major cardiovascular events such as heart attack in obese or overweight adults with established heart disease.