Benzinga | Dec 9, 2021 09:45PM EST

Intercept Announces Withdrawal Of EMA Marketing Authorization Application For Obeticholic Acid For Advanced Liver Fibrosis Due To NASH

Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that it has formally notified the European Medicines Agency (EMA) of its decision to withdraw its Marketing Authorization Application (MAA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH).



The initial MAA filing in December 2019 was supported by the positive interim analysis results from the pivotal Phase 3 REGENERATE study which remains ongoing. Intercept is in the process of generating additional efficacy and safety data from REGENERATE, including a full reread of Month 18 biopsies using a new consensus biopsy reading approach, as well as a robust body of adjudicated safety data, to support a potential refiling in the U.S. As disclosed previously, Intercept has been working with the Committee for Medicinal Products for Human Use (CHMP) to potentially include this data in the current MAA review process. However, the established application timeline could not be extended any further to allow for submission of the additional data -- which is expected in the early part of 2022 -- and based on their review of data submitted to date, the CHMP was not able to determine a positive benefit-risk. As a result, the Company has made the decision to withdraw the MAA.

"Advanced fibrosis due to NASH remains a significant unmet need in Europe. We are in the midst of producing the largest data package in the NASH field, which will include significantly more evidence regarding the benefit/risk of OCA in NASH," said Jerry Durso, President and Chief Executive Officer of Intercept. "Once we have the results of these new analyses, we will assess the possibility of submitting a new application to the EMA."