One of the last lines of defense against withdrawal of Ocaliva’s accelerated approval failed when the US Food and Drug Administration issued a complete response letter for Intercept Pharmaceuticals’ bid for full approval in primary biliary cholangitis with confirmation of clinical benefit.
Dark Skies For Ocaliva: US FDA Sides With AdComm In Complete Response Letter
The US FDA rejected Intercept’s bid to convert Ocaliva’s accelerated approval in primary biliary cholangitis, meaning withdrawal prospects loom.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.