Federal health regulators announced Monday their intention to revoke approval for a medication manufactured by Amgen that treats uncommon autoimmune conditions, following discoveries of serious safety issues and questionable approval processes.
The Food and Drug Administration’s drug evaluation division determined the medication, known as Tavneos, failed to demonstrate adequate effectiveness while also containing false information in its original approval submission.
Safety concerns escalated in March when federal investigators documented 76 instances of liver damage potentially linked to the medication. Among these cases, seven patients developed vanishing bile duct syndrome, a serious condition that can result in irreversible liver harm. Tragically, eight fatalities occurred within this group of affected patients.
The proposed withdrawal represents a significant regulatory action against the pharmaceutical company, highlighting ongoing concerns about drug safety monitoring and approval processes for treatments targeting rare medical conditions.
