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Novo Nordisk's Wegovy gets accelerated US approval for liver disease MASH
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Novo Nordisk's Wegovy gets accelerated US approval for liver disease MASH
Aug 15, 2025 3:15 PM

Aug 15 (Reuters) - 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 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.

(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by

Sriraj Kalluvila)

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