Posted by Michael Wonder on 25 Nov 2019
FDA accepts Intercept’s new drug application for OCA for the treatment of liver fibrosis due to NASH and grants priority review
25 November 2019 - NDA supported by positive interim analysis results from the Phase 3 REGENERATE study demonstrating OCA’s improvement of liver fibrosis without worsening of NASH.
Intercept Pharmaceuticals today announced that the U.S. FDA has accepted Intercept’s new drug application for obeticholic acid seeking accelerated approval for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH) and granted priority review.
The FDA has assigned a Prescription Drug User Fee Act target action date of 26 March 2020.
