Amgen seeks FDA hearing to keep rare kidney drug Tavneos amid safety concerns

Amgen has asked the U.S. Food and Drug Administration for a hearing to argue against a proposed withdrawal of its rare‑disease drug Tavneos.

The company submitted a data package containing real‑world evidence to support the drug’s benefit‑risk profile after the FDA raised concerns about liver toxicity earlier this year.

The issue intensified after reports that 20 patients in Japan died from a liver condition linked to the drug, prompting the local partner Kissei Pharmaceutical to briefly advise doctors to stop new prescriptions before reversing the guidance.

Amgen says it strongly disagrees with the FDA’s proposal and will use the hearing to defend Tavneos, which was approved in 2021 for ANCA‑associated vasculitis.