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EU regulator backs conditional authorisation for Madrigal's liver disease drug
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EU regulator backs conditional authorisation for Madrigal's liver disease drug
Jun 20, 2025 4:38 AM

June 20 (Reuters) - The European Union's drug regulator

on Friday recommended conditional authorisation of Madrigal

Pharmaceuticals' ( MDGL ) Rezdiffra, paving the way for it to

become the first available treatment in the region for patients

with a form of fatty liver disease.

Rezdiffra was first approved in the United States in March

last year. There are currently no authorised treatments for the

disease in the European Union.

The disease known as non-alcoholic steatohepatitis (NASH),

or more recently renamed as metabolic dysfunction-associated

steatohepatitis (MASH), causes an excess buildup of fat in the

liver, resulting in inflammation and fibrosis, or scarring, of

the organ.

The European Commission's decision on the drug is expected

in August, the company said.

Rezdiffra is indicated for patients with moderate to

advanced scarring due to accumulation of fat, the agency said.

The drug works by activating a thyroid hormone receptor in

the liver, reducing fat buildup, improving inflammation and

preventing further liver damage in NASH patients.

Madrigal expects to launch Rezdiffra in Europe, starting

with Germany in the second half of this year, the company said

in a conference call earlier this month.

The drug was recommended for a conditional marketing

authorisation, a mechanism used by the European Union to

facilitate early access to medicines that fulfill an unmet

medical need.

The conditional authorisation allows the agency to recommend

a medicine with less complete data than normally expected, if

the benefits of a medicine's immediate availability to patients

outweigh the risk.

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