Wegovy earns MASH approval

The FDA grants accelerated approval for Wegovy to treat metabolic dysfunction-associated steatohepatitis, expanding the drug’s use beyond obesity.

Wegovy gains FDA approval to treat MASH

The FDA granted accelerated approval to Wegovy for metabolic dysfunction-associated steatohepatitis, or MASH, in adults with moderate to advanced liver fibrosis. The decision rests on phase 3 data showing improvements in liver fibrosis and symptom relief in patients with obesity and metabolic dysfunction. The approval marks a shift in how existing therapies can address related organ disease while more data are collected.

MASH develops in people with fatty liver disease linked to obesity and metabolic dysfunction and can progress to cirrhosis or liver cancer. By extending Wegovy's use, regulators aim to address a growing health problem, but confirmatory trials will be required to verify long term safety and real world benefit. Payers and clinicians will watch closely how cost, access and ongoing safety play out in diverse patient populations.

The move mirrors a trend where obesity drugs are deployed to treat related conditions, broadening the scope of what these therapies can do. It reflects a push to connect weight management with liver health, a field still learning how such therapies affect different organs. The long term question is whether real world use will match trial results, and how tracking and pricing will keep these medicines affordable.

This decision will test the willingness of insurers and physicians to adopt new uses quickly. The outcome will depend on price, patient selection, and the robustness of confirmatory data. If safety holds and access improves, this could reshape chronic disease care beyond weight loss and shift how regulators evaluate multi disease therapies.

Highlights

The next chapters will reveal whether this approval translates into meaningful liver health gains over time.