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Ocaliva Confirmatory Trial Failed To Verify Benefit In Primary Biliary Cholangitis, US FDA Says

 
• By Sue Sutter

A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.  

Boxing ropes
Intercept may struggle to explain why Ocaliva should convert to regular approval. • Source: Shutterstock

Intercept Pharmaceuticals, Inc. may struggle to preserve the future of its primary biliary cholangitis drug Ocaliva (obeticholic acid) following the US Food and Drug Administration’s negative review of a confirmatory trial and real-world evidence study.

Intercept Pharmaceuticals, Inc., a wholly owned subsidiary of Alfasigma S.p.A., is seeking conversion of Ocaliva from accelerated to regular...

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