Posted by Michael Wonder on 24 Dec 2022
Intercept resubmits new drug application to US FDA for obeticholic acid in patients with liver fibrosis due to NASH
23 December 2022 - New drug application supported by robust NASH clinical development program, including two positive interim analyses from the Phase 3 REGENERATE study.
Intercept Pharmaceuticals today announced that it has resubmitted a new drug application to the US FDA for obeticholic acid for the treatment of patients with pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis.
