Intercept Pharma withdraws its MAA for obeticholic acid for the treatment of liver fibrosis due to NASH.
The initial MAA filing in December 2019 was supported by the positive interim analysis results from the pivotal Phase III 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.
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