About 6 percent of American adults have the disease, known as MASH.
The Food and Drug Administration has approved a weight loss drug called Wegovy for a liver disease, the agency announced on Aug. 18.
Wegovy is now approved for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that impacts approximately 6 percent of American adults, the FDA said in a statement.
Updated labeling for Wegovy now lists the treatment.
“The indication for MASH is approved under accelerated approval based on improvement of MASH and fibrosis,” it states. “Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.”
Data supporting the approval came from an interim analysis, at week 72, from a phase 3 double-blind, placebo-controlled trial that’s designed to last for 240 weeks. Patients who received Wegovy were more likely to experience improvement in liver scarring, with no worsening of liver disease.
MASH is also known as nonalcoholic fatty liver disease. The condition can develop in obese people and occurs when fat builds up in one’s liver. That causes inflammation, and can lead to severe problems such as liver cancer unless treated.
Wegovy was already approved for reducing weight in people who are at least 12 years of age “in combination with a reduced calorie diet and increased physical activity.”
It is also cleared for the reduction of cardiovascular events in adults who are oversight or obese, and have cardiovascular disease.
Wegovy is one of several glucagon-like peptide-1 (GLP-1) drugs that have been approved in recent years for weight loss and other purposes. The FDA initially approved Wegovy in 2021 for adults.
Side effects can include thyroid tumors and pancreatic inflammation.
Novo Nordisk, a European manufacturer, makes Wegovy and a similar product, Ozempic, both also known as semaglutide.
“Wegovy is now uniquely positioned as the first and only GLP-1 treatment approved for MASH, complementing the already proven weight loss, cardiovascular benefits and extensive body of evidence linked to semaglutide,” Martin Holst Lange, chief scientific officer at Novo Nordisk, said in a statement.
