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Dark Skies For Ocaliva: US FDA Sides With AdComm In Complete Response Letter

 
• By Bridget Silverman

The US FDA rejected Intercept’s bid to convert Ocaliva’s accelerated approval in primary biliary cholangitis, meaning withdrawal prospects loom.

Storms may be on the horizon for Intercept after Ocaliva received a complete response letter from the FDA in primary biliary cholangitis. (Shutterstock)
Key Takeaways
  • Ocaliva’s conversion from accelerated to regular approval in primary biliary cholangitis received a complete response letter from the US FDA, Intercept reported 12 November, nearly a month after the user fee goal date.
  • The CRL’s content is consistent with Ocaliva’s advisory committee review in September, which concluded clinical benefit was not verified and the benefit-risk profile was unfavorable.
  • The FDA still is reviewing safety data and other information, but Ocaliva’s chances of avoiding the withdrawal of its accelerated approval appear to be decreasing.

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

The CRL, announced 12 November, is “consistent with the outcome of the Gastrointestinal Drugs Advisory Committee” review of the Ocaliva (obeticholic acid) sNDA, Alfasigma subsidiary Intercept Pharmaceuticals said.

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