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NASH: Madrigal Files Resmetirom In EU While US Action Date Closes In

 
• By Neena Brizmohun

Resmetirom, which could become the first approved treatment for non-alcoholic steatohepatitis, is among 11 new drugs that the European Medicines Agency has started to review for potential EU approval. Meanwhile, a decision on whether to approve the drug in the US is due on 14 March.

Liver health
NASH is a more advanced form of non-alcoholic fatty liver disease • Source: Shutterstock

The European Medicines Agency has begun reviewing a new batch of drugs for potential pan-EU marketing approval, including resmetirom, Madrigal Pharmaceuticals’ THR-β agonist, which is awaiting a decision tomorrow on whether it will become the first approved treatment for non-alcoholic steatohepatitis (NASH) in the US.

Resmetirom is a once-daily, oral drug designed to target the key underlying causes of NASH, a potentially lucrative market that...

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