By Puyaan Singh
March 31 (Reuters) – The U.S. Food and Drug Administration on Tuesday said it has identified cases of liver injury in patients taking Amgen’s drug for a group of rare autoimmune diseases and urged healthcare providers to discontinue the treatment promptly if damage to the organ is suspected.
The agency said it has identified 76 cases of drug-induced liver injury with evidence suggesting a causal link to Tavneos, including seven cases of vanishing bile duct syndrome (VBDS), a rare condition that can cause permanent liver damage. Eight deaths were reported among those cases.
The safety warning adds to mounting regulatory scrutiny of Tavneos, which is approved to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, a group of rare autoimmune diseases that cause inflammation in small- to medium-sized blood vessels.
Last month, Amgen said the FDA asked it to voluntarily withdraw Tavneos after concerns emerged 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 drug, saying at the time it was not aware of any issues with the underlying patient data, remained confident in Tavneos’ benefit-risk profile and was working with the FDA on next steps.
The drugmaker told Reuters on Tuesday it is “confident that Tavneos is an important and effective medicine.”
In January, the European Medicines Agency said it started a review of Tavneos “following emerging information that raises questions regarding the data integrity (of its study).”
While Tavneos labels in Europe and Australia mention post-marketing cases of vanishing bile duct syndrome, the U.S. prescribing information does not currently warn of it, according to the FDA’s website.
Amgen said it had submitted a proposed update in 2024 to the FDA to add VBDS to the Tavneos label, “a request that is still pending.”
(Reporting by Puyaan Singh in Bengaluru; Editing by Tasim Zahid and Jonathan Ananda)
