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Intercept’s Ocaliva Falls At US FDA Panel; Is Accelerated Approval Withdrawal On The Horizon?

 
• By Sue Sutter

Obeticholic acid has not confirmed clinical benefit and the benefit-risk profile is not favorable in primary biliary cholangitis, the FDA advisory committee said. The agency must now decide whether to keep Ocaliva on the market with new study requirements or seek withdrawal.

Horizon
Is withdrawal in the US on the horizon for Ocaliva? • Source: Shutterstock

Continued US marketing of Intercept Pharmaceuticals, Inc.’s primary biliary cholangitis treatment Ocaliva (obeticholic acid) is in doubt following a US Food and Drug Administration panel’s conclusion that the accelerated approval drug has not confirmed clinical benefit and lacks a favorable benefit-risk profile.

At a 13 September meeting, 13 of 14 members of the Gastrointestinal Drugs Advisory Committee said the available evidence does not verify the benefit of obeticholic acid (OCA) on clinical outcomes in the labeled population

Key Takeaways

  • An advisory committee majority said Ocaliva has not confirmed clinical benefit and does not have a favorable benefit-risk profile.

  • The FDA now must decide whether to withdraw the accelerated approval drug or keep it on the market with a requirement for new studies

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