FDA accepts Intercept NDA for OCA to treat NASH pre-cirrhotic liver fibrosis

Intercept Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted Intercept’s New Drug Application NDA for obeticholic acid OCA seeking accelerated approval for the treatment of patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis, NASH. FDA indicated that it considers this a complete, Class 2 resubmission and has assigned a Prescription Drug User Fee Act PDUFA target action date of June 22 for the NDA. The timeline for the review of the NDA by FDA remains subject to change. "This regulatory milestone brings us one step closer to reaching our goal of delivering the first available therapy for patients living with pre-cirrhotic fibrosis due to NASH – the most rapidly growing cause of liver transplantation in the U.S.," said Jerry Durso, President and Chief Executive Officer of Intercept. "We believe OCA has the potential to become an important therapy given its strong and direct antifibrotic effect, and we look forward to continuing our work with FDA over the coming months as they review our NDA."