Intercept Pharmaceuticals, Inc. has reached agreement with the US Food and Drug Administration on a process for retrospective analysis of its pivotal Phase III REGENERATE study of obeticholic acid (OCA) in non-alcoholic steatohepatitis-related fibrosis that will satisfy the agency’s expectations for consensus central review of the data.
Intercept Plans To Refile OCA For NASH At US FDA With Consensus Reads Of Patient Biopsies
Additional patients and more long-term data could also help make case for obeticholic acid. Intercept hopes to complete its review of the pivotal REGENERATE trial during H1 2022.
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