Posted by Michael Wonder on 10 Dec 2021
Intercept announces withdrawal of EMA marketing authorisation application for obeticholic acid for advanced liver fibrosis due to NASH
9 December 2021 - Intercept Pharmaceuticals today announced that it has formally notified the EMA of its decision to withdraw its marketing authorisation application for obeticholic acid for the treatment of liver fibrosis due to nonalcoholic steatohepatitis.
The initial filing of the marketing authorisation application by Intercept in December 2019 was supported by the positive interim analysis results from the pivotal Phase 3 REGENERATE trial which remains on-going.
