(Reuters) -The European Union’s drug regulator on Friday recommended conditional authorisation of Madrigal Pharmaceuticals’ 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.
(Reporting by Sriparna Roy and Kamal Choudhury in Bengaluru; Editing by Shinjini Ganguli)
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