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Intercept Wants More Time to Address EMA’s Questions Over Its NASH Treatment

EU Review Of Obeticholic Acid Began Around 18 Months Ago

 
• By Vibha Sharma

The marketing application for obeticholic acid, Intercept’s potential new treatment for advanced fibrosis due to nonalcoholic steatohepatitis (NASH), was rejected in the US and now the company says it needs extra time to respond to questions about its EU filing.

liver
There are currently no approved medications for treatment of NASH • Source: Shutterstock

Intercept Pharmaceuticals is seeking extra time to address late-stage queries EU regulators have about the company’s marketing application for obeticholic acid (OCA), a potential new treatment for advanced fibrosis due to nonalcoholic steatohepatitis (NASH), the most severe form of non-alcoholic fatty liver disease.

The drug is at the later stages of review at the European Medicines Agency, where it has been under evaluation since January 2020. Also see "Intercept Eyes EU NASH...

Clock Stops During CHMP Evaluation

The standard assessment of a marketing authorization application (MAA) for a new medicine at the European Medicines Agency takes up to 210 ‘active’ days. This time may...

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