Posted by Michael Wonder on 28 Sep 2019
Intercept submits new drug application to the U.S. FDA for obeticholic acid in patients with fibrosis due to NASH
27 September 2019 - NDA supported by positive interim analysis results from REGENERATE Phase 3 study demonstrating OCA’s improvement of liver fibrosis without worsening of NASH.
Intercept Pharmaceuticals today announced that it has submitted a new drug application to the U.S. FDA for obeticholic acid (OCA) for the treatment of patients with fibrosis due to nonalcoholic steatohepatitis (NASH).
OCA is the only investigational therapy to meet the primary endpoint of a Phase 3 study in patients with NASH and is the only such therapy that the FDA has designated a breakthrough therapy for NASH with fibrosis. As such, Intercept has requested a priority review for the NDA, which, if granted, would result in an anticipated six month review period.
The submission is based on positive interim analysis results from the pivotal Phase 3 REGENERATE study in patients with liver fibrosis due to NASH. In the study, OCA 25 mg achieved its primary endpoint by demonstrating robust improvement in liver fibrosis (by ≥1 stage) without worsening of NASH at 18 months (p=0.0002 vs placebo).
