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Intercept Withdraws EU NASH Drug Filing But May Retry

 
• By Neena Brizmohun

New data that is being collected to support a US resubmission for Intercept’s obeticholic acid might also be used to support a resubmission to the European Medicines Agency.

Liver is a Part Human Body Internal Organs Anatomy. 3D
Intercept is collecting more data to support its drug for liver fibrosis due to NASH • Source: Alamy

Intercept Pharmaceuticals is withdrawing its EU marketing authorization application (MAA) for obeticholic acid (OCA), an investigational treatment for liver fibrosis due to nonalcoholic steatohepatitis (NASH) that also suffered a setback in the US but which the company hopes to resubmit in that jurisdiction soon.

Intercept, which could become the first company with an approved NASH drug, decided to withdraw the EU MAA after learning that the European Medicines Agency could not determine a positive...

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