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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Ahead of advisory committee vote on accelerated approval, agency takes a dim view of obeticholic acid's benefit-risk balance for the treatment of liver fibrosis due to NASH, citing risks of drug-induced liver injury and morbidity associated with biopsies necessary for appropriate patient selection.
The new analysis of REGENERATE, based on an FDA-requested methodology, shows continued efficacy for OCA, but analysts were circumspect about whether the benefit/risk profile would sway the agency.
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.