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Intercept Ends NASH Development, But Other Firms’ FXR Agonist Programs Ongoing

 
• By Joseph Haas

While Intercept is calling it quits in NASH with its FXR agonist obeticholic acid following a second complete response letter, other companies are staying the course with Phase II molecules in the class.

Dominoes
Intercept followed a second CRL by announcing its exit from NASH R&D • Source: Shutterstock

The dominos fell as expected in the non-alcoholic steatohepatitis (NASH) R&D space as Intercept Pharmaceuticals, Inc. announced late on 22 June that it had received a second complete response letter from the US Food and Drug Administration for obeticholic acid (OCA) in pre-cirrhotic NASH and told investors it was ending activity in the space. What remains unknown is how the fate of OCA, an FXR agonist, may read through to the rest of the burgeoning and varied NASH development race.

The CRL came as no surprise following a vote from the agency’s Gastrointestinal Drugs Advisory Committee on 19 May against recommending accelerated approval for OCA in NASH. At the time,...

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