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

 
• By Joseph Haas
  
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AASLD Briefing: While working on new biopsy reviews to address CRL, Intercept also might consider filing for approval in cirrhotic patients if REVERSE study succeeds. Plus other updates on NASH programs.

Liver disease
Intercept, Madrigal, Akero, 89Bio update their progress at AASLD

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on a three-pathologist review process that will meet the requirement for central reading of scans set in a draft guidance that the FDA issued earlier this year, chief medical officer Michelle Berrey told Scrip in an interview.

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