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Could Another US FDA Safety Alert Foreshadow Withdrawal Of Intercept’s Ocaliva?

 
• By Sue Sutter

The FDA's view that current monitoring recommendations may not be sufficient to mitigate harm increases the likelihood it could seek withdrawal.

Caution warning
US FDA has issued a fourth safety alert related to liver injury for Intercept's Ocaliva. (Shutterstock)
Key Takeaways
  • An FDA safety alert cites clinical data showing an elevated risk of liver transplant and death among Ocaliva recipients compared to placebo, and postmarketing reports of liver-related events in patients who should have discontinued therapy.
  • The safety alert is the fourth about the primary biliary cholangitis treatment since its May 2016 accelerated approval.
  • The communication could mark an interim step while CDER formalizes a withdrawal request, or help pressure Intercept to voluntarily withdraw the drug.


The US Food and Drug Administration is once again warning about an increased risk of serious liver injury with

In a 12 December safety communication, the FDA said it identified serious liver injury cases that resulted in transplant and death among clinical trial

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