Tags: wegovy | novo nordisk | fda | accelerated | approval | liver | mash

Wegovy Gets Accelerated Approval for Liver Disease

Wegovy in box, injection
(Dreamstime)

Monday, 18 August 2025 10:25 AM EDT

Novo Nordisk said on Friday the U.S. Food and Drug Administration had granted accelerated approval for its weight-loss drug Wegovy to treat a serious liver condition known as metabolic dysfunction-associated steatohepatitis.

Alert: Will You Take Care of Your Liver Before It's Too Late? Read More!

The decision makes Wegovy the first GLP-1 class therapy cleared for MASH, a progressive liver condition that affects around 5% of adults in the U.S., according to the American Liver Foundation.

The approval is for use alongside a reduced-calorie diet and increased physical activity.

The FDA's approval was based on part 1 of a two-part study that showed Wegovy helped more patients with MASH and liver scarring improve the organ's condition, compared to a placebo.

At 72 weeks, nearly 37% of patients on Wegovy saw an improvement in liver fibrosis, compared to 22.4% on placebo.

Nearly 63% of those on Wegovy had their liver inflammation resolved, versus 34.3% for placebo. No worsening of the disease was seen in these patients.

Accelerated approvals allow the agency to move therapies that target serious and life-threatening conditions to the market more quickly.

However, such approvals have been criticized because some drugs have later been proven to be ineffective. 

© 2025 Thomson/Reuters. All rights reserved.


Health-News
Novo Nordisk said on Friday the U.S. Food and Drug Administration had granted accelerated approval for its weight-loss drug Wegovy to treat a serious liver condition known as metabolic dysfunction-associated steatohepatitis. The decision makes Wegovy the first GLP-1 class...
wegovy, novo nordisk, fda, accelerated, approval, liver, mash
200
2025-25-18
Monday, 18 August 2025 10:25 AM
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