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.