Intercept seeks US accelerated obeticholic acid OK; MAA accepted
This article was originally published in Scrip
Intercept Pharmaceuticals submitted a new drug application (NDA) to the FDA for obeticholic acid, which the firm said is the first medication in decades to seek the agency's approval for primary biliary cirrhosis (PBC), a rare liver disease that primarily results from autoimmune destruction of the ducts that transport bile acids out of the liver, resulting in cholestasis.
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