Intercept Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that it has submitted its Marketing Authorization Application to the European Medicines Agency for obeticholic acid for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH). The MAA submission is supported by the positive interim analysis results from the pivotal Phase 3 REGENERATE study in patients with liver fibrosis due to NASH.
Intercept also announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative date for the previously announced advisory committee meeting related to Intercept’s New Drug Application for OCA in liver fibrosis due to NASH. The FDA has tentatively scheduled the AdCom for April 22, 2020. Intercept anticipates that the FDA accordingly will extend the recently announced March 26, 2020 Prescription Drug User Fee Act target action date for Intercept’s NDA. Intercept previously announced the FDA’s acceptance of the NDA and granting of priority review.
“NASH is quickly becoming one of the most significant public health challenges in Europe and costs associated with advanced fibrosis and cirrhosis are estimated to represent approximately 95% of the total NASH related costs to health care systems,”
said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept.
“We believe that OCA has the potential to become an essential treatment for people living with advanced fibrosis due to NASH and we look forward to working with the EMA during this review period. Separately, we are pleased that FDA has provided us with the tentative AdCom date and we look forward to working collaboratively with the agency during its review of the NDA as we continue to prepare for our anticipated NASH launch, if approved, within the first half of 2020.”