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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Still working to refile its NASH fibrosis NDA 22 months after an FDA complete response letter, Intercept gets $405m up front for its ex-US business, including commercial rights to Ocaliva in PBC.
New data that is being collected to support a US resubmission for Intercept’s obeticholic acid might also be used to support a resubmission to the European Medicines Agency.
CEO Durso says Intercept is aiming to refile its NDA by end of 2021, but several departures in recent months indicate pessimism on NASH prospects to some analysts.