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Wegovy is first GLP-1 treatment approved for MASH

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FDA decision based on part one of an ongoing study

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Novo Nordisk seeks approval in Europe and Japan

By Padmanabhan Ananthan

Aug 15 (Reuters) - Novo Nordisk said on

Friday the U.S. Food and Drug Administration has granted

accelerated approval for its weight-loss drug Wegovy to treat a

serious liver condition called metabolic dysfunction-associated

steatohepatitis, strengthening its presence in the metabolic

disease market.

The approval makes Wegovy the first GLP-1 class therapy

cleared for MASH, a progressive liver condition that affects

around 5% of adults in the United States, according to the

American Liver Foundation.

"There really (have) not been good treatments in this space.

We're only the second FDA-approved treatment for MASH, and we

really need better medications that have better overall

benefit-risk profiles, that really can also prevent the

progression of the disease," Jason Brett, principal U.S. medical

head at Novo Nordisk, said in an interview with Reuters.

So far, the only available FDA-approved treatment for MASH

is the Madrigal Pharmaceuticals ( MDGL ) drug Rezdiffra, which

was approved in 2024.

The FDA's decision was based on part one of an ongoing

two-part study that showed Wegovy helped improve the organ's

condition in more patients with MASH and liver scarring,

compared to a placebo.

Novo Nordisk said the drug is now available in the United

States for adults with MASH and moderate to advanced liver

scarring, and is to be used alongside proper diet and exercise.

"MASH patients need access to treatments - and that really

can help them, especially early - to prevent it from

progressing," Brett said. "We're doing as much as we can to work

and partner with the payer community around enhancing access and

reimbursement."

Brett did not provide any pricing details.

Based on results from part one of the trial, Novo has

applied this year for approval in Europe and Japan. Further

results from part two of the trial are expected in 2029.

Rival Eli Lilly's ( LLY ) tirzepatide - the active

ingredient in its popular diabetes drug Mounjaro and weight-loss

treatment Zepbound - previously helped up to 74% of patients

achieve absence of MASH with no worsening of scarring in a

mid-stage trial.

Accelerated approvals allow the FDA 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.