{"id":633226,"date":"2025-08-20T14:10:03","date_gmt":"2025-08-20T18:10:03","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=633226"},"modified":"2025-08-20T14:10:03","modified_gmt":"2025-08-20T18:10:03","slug":"wegovy-liver-disease-fda-approval","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/wegovy-liver-disease-fda-approval\/","title":{"rendered":"FDA approves Wegovy for liver disease"},"content":{"rendered":"

The U.S. Food and Drug Administration (FDA) has expanded the approval for the popular injectable weight-loss drug <\/span>Wegovy (semaglutide)<\/span><\/a> to include the treatment of a serious form of fatty liver disease known as metabolic-associated steatohepatitis (MASH). This condition was also previously called nonalcoholic steatohepatitis (NASH). Specifically, the accelerated approval was to treat MASH in adults with moderate to severe liver scarring, but not cirrhosis of the liver, in conjunction with a <\/span>reduced-calorie diet<\/span><\/a> and increased physical activity.\u00a0<\/span><\/p>\n

“For far too long, this disease has remained unrecognized, undiagnosed, and often untreated, despite impacting so many people,” said Dave Moore, executive vice president of U.S. Operations at Novo Nordisk, in a statement. “The FDA’s conditional approval of Wegovy for the treatment of adults with noncirrhotic MASH marks a truly pivotal milestone and a significant step forward for the MASH community and those seeking new options. This builds on the expanding body of evidence demonstrating the clinical benefits of semaglutide across a range of chronic conditions, including diabetes, obesity, cardiovascular, and chronic kidney disease.”<\/span><\/p>\n

What is Wegovy?<\/span><\/h2>\n

Novo Nordisk\u2019s <\/span>Wegovy<\/span><\/a> belongs to a class of medications known as <\/span>glucagon-like peptide-1 receptor agonists<\/span><\/a> (<\/span>GLP-1 agonists<\/span><\/a>)<\/span>. These drugs are designed to treat Type 2 diabetes, obesity, and a growing number of related conditions.\u00a0<\/span><\/p>\n

Granted on August 15, the accelerated approval marks the third time that the FDA has expanded or approved a new indication for Wegovy. Wegovy first received approval in 2021 for weight loss in adults with obesity (or overweight with weight-related medical problems), along with reduced calorie intake and increased physical activity. In 2022, the FDA expanded that indication to include children aged 12 years and older with obesity.<\/span><\/p>\n

Then, in March 2024, <\/span>the FDA approved<\/span><\/a> Wegovy to <\/span>reduce the risk of cardiovascular death, heart attack, and stroke in adults<\/span><\/a> with cardiovascular disease who are either overweight or have obesity.\u00a0<\/span><\/p>\n

How does Wegovy help with MASH?<\/span><\/h2>\n

The latest approval was based on part of the phase 3 ESSENCE trial, which found that a once-weekly 2.4 mg injection of Wegovy helped <\/span>63% of people<\/span><\/a> treated achieve resolution of steatohepatitis without any worsening of liver fibrosis or scarring.\u00a0<\/span><\/p>\n

Wegovy promotes weight loss and potentially other mechanisms not fully understood, which may <\/span>improve liver inflammation and scarring<\/span><\/a>. While Wegovy is now the only GLP-1 specifically FDA approved for this purpose, Wegovy is just one of several FDA-approved medications that contain semaglutide. The others are <\/span>Ozempic injections<\/span><\/a> and <\/span>Rybelsus tablets<\/span><\/a>.\u00a0<\/span><\/p>\n

\u201cThe FDA\u2019s approval of Wegovy is exciting for sure,\u201d says <\/span>Supriya Rao<\/span><\/a>, MD, managing partner of Integrated Gastroenterology Consultants and the Director for Medical Weight Loss at Lowell General Hospital in Massachusetts. \u201cThis could quite literally be life-saving. For patients with obesity who also have fatty liver disease, it offers real hope that we can slow down or stop the progression to cirrhosis.\u201d<\/span><\/p>\n

Expanding MASH treatment options<\/span><\/h2>\n

The expanded approval for Wegovy could be good news for a growing number of people with severe liver disease. Nearly <\/span>14.9 million people<\/span><\/a>, or about 6% of U.S. adults, have MASH, and the numbers are expected to grow.\u00a0<\/span><\/p>\n

MASH occurs when too much fat builds up in the liver, which causes inflammation. It develops slowly over the years, and many people don\u2019t develop any symptoms until their liver has already sustained significant damage. <\/span>MASH can lead to<\/span><\/a> severe liver scarring known as cirrhosis, hepatitis, worsening of liver function, liver cancer, and even the need for liver transplant.\u00a0<\/span><\/p>\n

Current treatments<\/span><\/a> often used to treat MASH include:<\/span><\/p>\n