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

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