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Intercept Could Face Tougher Road To NASH Approval In EU Than US

 
• By Joseph Haas

Recently filed NDA for obeticholic acid relies on US FDA's specified endpoints for treatment of fibrosis, but European standards are less clear cut, the company acknowledges.

Busy-City
The busy pace continues in NASH as Intercept files an NDA; Galmed moves into Phase III

Intercept Pharmaceuticals Inc. will follow up its US new drug application for obeticholic acid (OCA) in NASH with a filing with the European Medicines Agency by the end of the year, but the company doesn't necessarily expect the EMA review to go as smoothly. 

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