FDA approves Wegovy for liver disease

In this article:

• What is Wegovy?
• How it helps
• MASH treatment
• Side effects
• Insurance
• Cost
• Availability

In this article

• What is Wegovy?
• How it helps
• MASH treatment
• Side effects
• Insurance
• Cost
• Availability

The U.S. Food and Drug Administration (FDA) has expanded the approval for the popular injectable weight-loss drug Wegovy (semaglutide) 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 reduced-calorie diet and increased physical activity. 

“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.”

What is Wegovy?

Novo Nordisk’s Wegovy belongs to a class of medications known as glucagon-like peptide-1 receptor agonists (GLP-1 agonists). These drugs are designed to treat Type 2 diabetes, obesity, and a growing number of related conditions. 

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.

Then, in March 2024, the FDA approved Wegovy to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease who are either overweight or have obesity. 

How does Wegovy help with MASH?

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 63% of people treated achieve resolution of steatohepatitis without any worsening of liver fibrosis or scarring. 

Wegovy promotes weight loss and potentially other mechanisms not fully understood, which may improve liver inflammation and scarring. 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 Ozempic injections and Rybelsus tablets. 

“The FDA’s approval of Wegovy is exciting for sure,” says Supriya Rao, MD, managing partner of Integrated Gastroenterology Consultants and the Director for Medical Weight Loss at Lowell General Hospital in Massachusetts. “This 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.”

Expanding MASH treatment options

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

MASH occurs when too much fat builds up in the liver, which causes inflammation. It develops slowly over the years, and many people don’t develop any symptoms until their liver has already sustained significant damage. MASH can lead to severe liver scarring known as cirrhosis, hepatitis, worsening of liver function, liver cancer, and even the need for liver transplant. 

Current treatments often used to treat MASH include:

• Lifestyle changes such as eating a healthy diet, avoiding alcohol, and getting regular exercise
• Oral medications such as Rezdiffra (resmetirom), which is approved to help reduce scarring in the liver in people with MASH with fibrosis stages 2 and 3. It belongs to a class of medications called thyroid hormone receptor (THR)-beta agonists

It’s important to get regular checkups, especially if you have risk factors for MASH, such as Type 2 diabetes, high cholesterol, high triglycerides, high blood pressure, insulin resistance, obesity, or being overweight. Your healthcare provider can order blood tests to measure your liver enzymes if they suspect that you may be developing MASH. 

What are the side effects of Wegovy?

The most common side effects of Wegovy are gastrointestinal complaints, such as:

• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• Bloating
• Gas
• Constipation

Other common side effects include:

• Headache
• Fatigue
• Dizziness
• Runny nose
• Sore throat

People with Type 2 diabetes may experience low blood sugar. However, more serious side effects are possible. For example, drugs like semaglutide are associated with certain types of thyroid cancers in animal studies. The risk is not known in humans, but the manufacturer cautions that people with a personal or family history of medullary thyroid carcinoma (MTC) or those with a condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) should not take Wegovy. 

RELATED: Do the side effects of Wegovy go away?

Will insurance cover Wegovy for MASH?

It’s likely that insurance will cover Wegovy for MASH, though coverage varies by plan and policies. However, you may need prior authorization or to demonstrate certain criteria, such as advanced liver fibrosis without cirrhosis, before your insurance will cover this prescription. Contact your insurance company to verify coverage.

How much does Wegovy cost?

Earlier this year, Novo Nordisk announced that it was lowering the cost of a month’s supply of Wegovy from $650 to $499. Some insurance plans may cover some of the cost, but others may not. However, people for whom cost is a concern may also be able to use the SingleCare prescription discount card to reduce out-of-pocket costs.

Wegovy coupons

When will Wegovy be available for MASH?

Because this drug was already approved to treat obesity, it is available at pharmacies across the U.S. today.