Intercept Could Face Tougher Road To NASH Approval In EU Than US
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.
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No Read-Through Expected: NASH Field Unfazed By Intercept’s FDA Rejection
Execs from Madrigal, Cirius and Axcella say the FDA’s complete response letter is specific to shortcomings of Intercept’s OCA – and leaves the race to be first to market wide open again.
Galectin’s NASH Phase III Trial Will Use Surrogate Measures Of Esophageal Varices
Other NASH registration trails have targeted fibrosis, but Galectin's mostly-resolved discussions with US FDA will allow the belapectin program to focus of signs and symptoms of the disease.
Will A US FDA Advisory Committee Be In Intercept's Future?
There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.