The U.S. Food and Drug Administration announced on Tuesday that it has identified cases of liver injury in patients taking Amgen’s drug for a group of rare autoimmune diseases. The agency urged healthcare providers to promptly discontinue the treatment if any signs of liver damage are suspected.
There have been 76 reported cases of drug-induced liver injury linked to Tavneos, including seven instances of vanishing bile duct syndrome (VBDS), a rare condition that can lead to permanent liver damage. Among these cases, eight deaths have been reported.
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The recent safety warning adds to growing regulatory scrutiny of Tavneos, which is approved for the treatment of anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, a rare group of autoimmune diseases that cause inflammation in small- to medium-sized blood vessels.
Last month, Amgen reported that the FDA requested a voluntary withdrawal of Tavneos after concerns arose during a re-evaluation of primary endpoint data for nine of the 331 patients enrolled in the late-stage trial supporting its approval.
Amgen declined to withdraw the medication, stating that it had not identified any issues with the underlying patient data, remained confident in Tavneos’ benefit-risk profile, and was continuing to work with the FDA on next steps.
In January, the European Medicines Agency announced that it had launched a review of Tavneos “following emerging information that raises questions regarding the integrity of the study data.”
While Tavneos labels in Europe and Australia already include references to post-marketing cases of vanishing bile duct syndrome (VBDS), the U.S. prescribing information currently does not provide a warning about the condition.
Amgen stated that it submitted a proposed label update to the FDA in 2024 to include VBDS, noting that the request is still under review.
