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Author Topic: Intercept’s Drug for NASH Performs Well Enough for FDA Submission  (Read 10067 times)

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Offline Hep Editors

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An advanced trial of Intercept Pharmaceuticals’ experimental non-alcoholic steatohepatitis (NASH) treatment found it improved liver fibrosis with no worsening of NASH among participants. The company plans to submit its application for approval of the treatment, obeticholic acid (OCA), to the Food and Drug Administration (FDA) during the second half of 2019.

The Phase III REGENERATE study is a randomized, double-blind placebo-controlled multicenter trial evaluating the safety and efficacy of OCA among 931 people with Stage 2 or 3 liver fibrosis due to NASH. For the FDA to consider the treatment successful, OCA needed to have achieved at least one of two endpoints after 18 months: 1) a one-stage improvement in fibrosis with no worsening of NASH; or 2) a resolution of NASH with no worsening of fibrosis.



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