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Intercept Plans To Refile OCA For NASH At US FDA With Consensus Reads Of Patient Biopsies

 
• By Joseph Haas

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.

liver
• Source: Shutterstock

Intercept Pharmaceuticals, Inc. has reached agreement with the US Food and Drug Administration on a process for retrospective analysis of its pivotal Phase III REGENERATE study of obeticholic acid (OCA) in non-alcoholic steatohepatitis-related fibrosis that will satisfy the agency’s expectations for consensus central review of the data.

Seeking to become the first company with an approved NASH drug, Intercept hopes to have data ready for a refiling of its new drug application during the first half of...

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