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Factbox-Madrigal's drug wins first US approval for fatty liver disease NASH as rivals circle

FILE PHOTO: The headquarters of the U.S. Food and Drug Administration is shown in Silver Spring near Washington

(Reuters) - Madrigal Pharmaceuticals' drug became the first to win regulatory approval to treat a serious type of fatty liver disease formerly known as non-alcoholic steatohepatitis (NASH) as the race to tap a multi-billion dollar market intensifies.

The approval on Thursday follows limited success to develop a treatment for the disease, which is closely tied to obesity and is spreading fast.

The following companies are also developing treatments for NASH, formally known as metabolic dysfunction-associated steatohepatitis:

Company Drug name / Further Recent updates

developmental plans

stage

Akero Efruxifermin Drug being The drug

Therapeutics (Mid-stage) tested in significantly

two ongoing reduced scarring

late-stage after nearly two

studies and years in the

a separate mid-stage study,

mid-stage data showed in

study March

Altimmune Pemvidutide Mid-stage Drug, in

(Mid-stage) trial data December 2022,

for the achieved more

drug than 75%

expected in reduction in

first liver fat

quarter of content,

2025 compared to

placebo in an

early-stage

trial

Boehringer Survodutide Full trial Trial data from

Ingelheim (Mid-stage) data to be February showed

and presented significant

Zealand Pharma in coming improvement in

months liver

inflammation and

damage without

worsening

fibrosis or

scarring

Eli Lilly Tirzepatide - The drug helped

(Mid-stage) up to 74% of

patients achieve

"absence of the

disease" at 52

weeks, compared

to 13% of

patients on

placebo

Ionis ION224 - Trial data

Pharmaceuticals (Mid-stage) published in

Inc March showed

significant

improvement in

liver

inflammation and

damage without

worsening

fibrosis or

scarring

Merck & Co Efinopegdutide - Mid-stage trial

(Mid-stage) data from June

showed that

efinopegdutide

significantly

reduced liver

fat in patients

compared to

semaglutide

Novo Nordisk Semaglutide Late-stage No data

(Late-stage) study

expected to

enroll

about 1,200

patients

Viking VK2809 Additional The drug, in

Therapeutics (Mid-stage) data from May, helped

the study significantly

to be reduce liver fat

presented in patients

in the

first half

of 2024

89bio Pegozafermin Company Began first

(Late-stage) expects to late-stage study

begin for the drug on

second Wednesday, which

late-stage is intended to

trial in support a filing

MASH for accelerated

patients in approval in the

the second U.S.

quarter of

2024

(Reporting by Pratik Jain and Mariam Sunny in Bengaluru; Editing by Sriraj Kalluvila and Shounak Dasgupta)