Fair chance of nod for first NASH therapy in USA, says GlobalData
Pharma industry analyst GlobalData has highlighted the strength of data supporting a submission from US biotech Intercept Pharmaceuticals (Nasdaq: ICPT) in non-alcoholic steatohepatitis (NASH).
Intercept Pharmaceuticals (Nasdaq: ICPT) is developing obeticholic acid (OCA) as a treatment for people with pre-cirrhotic liver fibrosis due to NASH, and the US regulator is currently reviewing data from the trial program.
The company has had a bumpy ride to get to this point, with the US Food and Drug Administration issuing a Complete Response Letter (CRL) regarding an earlier submission.
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