NASH Updates: Intercept Moves Toward Re-Filing, Madrigal De-Risks Phase III

Intercept Pharmaceuticals, Inc. hopes to have data ready during the first half of 2022 to resubmit obeticholic acid (OCA) for non-alcoholic steatohepatitis-related fibrosis following the June 2020 complete response letter. The company reached an agreement with the US Food and Drug Administration on a three-pathologist review process that will meet the requirement for central reading of scans set in a draft guidance that the FDA issued earlier this year, chief medical officer Michelle Berrey told Scrip in an interview.

At the American Association for the Study of Liver Diseases annual meeting held 12-15 November, Intercept presented a poster detailing the consensus biopsy reading process it is using to re-evaluate the data from the pivotal Phase III REGENERATE trial, which showed OCA meeting statistical significance for reducing fibrosis by