Intercept Pharmaceuticals has submitted an NDA to the FDA for obeticholic acid for the treatment of patients with fibrosis due to nonalcoholic steatohepatitis (NASH).

Intercept Pharmaceuticals, Inc. announced that it has submitted a New Drug Application (NDA) to the 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 III 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 III 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). Intercept also intends to file a marketing authorization application (MAA) with the European Medicines Agency in the fourth quarter of this year.