Madrigal wins EC approval for Rezdiffra in MASH
The European Commission (EC) has granted conditional marketing authorization for Madrigal Pharmaceuticals' (Nasdaq: MDGL) Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis.
Rezdiffra is now the first and only approved therapy in the European Union (EU) for the treatment of MASH. The drug was the first ever MASH treatment approved last year in the USA, where last week Novo Nordisk won approval of this indication for its Wegovy (semaglutide).
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