Confirmatory trial reports clinical outcomes of obeticholic acid in primary biliary cholangitis, highlighting therapy verification after conditional approval.
Obeticholic acid (OCA) treatment for primary biliary cholangitis (PBC) was conditionally approved in the phase 3 POISE trial. The COBALT confirmatory trial assessed whether clinical outcomes in patients with PBC improve with OCA therapy.
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Kowdley et al. (2024) studied this question.
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