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2018 International Liver Congress

Ocaliva POISE'd to move beyond PBC with long-term fibrosis finding

By Marie Powers
News Editor

Monday, April 16, 2018

PARIS – Biopsy data from a subgroup of patients enrolled in Intercept Pharmaceuticals Inc.'s phase III POISE study of Ocaliva (obeticholic acid, or OCA) for the treatment of primary biliary cirrhosis (PBC) confirmed stabilization or regression of fibrosis/cirrhosis in 85 percent of the cohort following three years of treatment. The findings provided the first evidence that improvements in biochemical markers of PBC observed in previous studies are accompanied by antifibrotic effects suggested in preclinical trials of Ocaliva, which gained accelerated approval in 2016 to treat individuals with PBC who had an incomplete response to ursodeoxycholic acid (UDCA).

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