Amgen has submitted a package of data and analyses to the U.S. Food and Drug Administration (FDA) as part of its effort to obtain a hearing and prevent the withdrawal of Tavneos, its treatment for ANCA-associated vasculitis (AAV), from the U.S. market.
The drug, which Amgen acquired through its $3.7 billion purchase of ChemoCentryx in 2022, has faced increasing regulatory scrutiny in the United States and Europe. Concerns have focused on liver-related safety issues and questions surrounding the phase 3 ADVOCATE trial that supported the medicine’s approvals in the United States, European Union and other regions.
Earlier this year, the FDA asked Amgen to voluntarily withdraw Tavneos from the U.S. market. The company declined and instead began the process of requesting a hearing. In Europe, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended in late June that the drug’s marketing authorization be rescinded.
The submission includes an independent review of the ADVOCATE study conducted by the Duke Clinical Research Institute (DCRI), as well as real-world evidence, safety analyses, and patient and healthcare professional testimonials. The ADVOCATE trial has remained under scrutiny after the FDA alleged that study results had been manipulated. The matter was further complicated when The New England Journal of Medicine retracted the phase 3 study results that were originally published in 2021. According to the retraction notice, an FDA investigation found that primary endpoint assessments in nine patients were re-adjudicated after the database lock and trial unblinding.
Amgen said the DCRI review confirmed the noninferiority of Tavneos compared with a prednisone taper regimen for remission at week 26 and sustained remission at week 52. The company noted that the re-analysis did not demonstrate superiority for Tavneos at week 52, unlike the original study findings. However, Amgen said the overall findings remained similar to the original ADVOCATE results, with a treatment effect that directionally favored Tavneos for sustained remission.
In support of its position, Amgen also submitted a comparative effectiveness study, a meta-analysis, and post-marketing safety data. Using its global safety database, the company reported approximately 31 serious hepatic adverse events per 1,000 patient-years. According to Amgen, most reported events were reversible laboratory abnormalities. The company also acknowledged cases of serious liver injury and vanishing bile duct syndrome, including cases that resulted in death, predominantly among Japanese patients older than 65.
Liver toxicity concerns had been identified during Tavneos’ clinical development and led to liver monitoring recommendations being included in the U.S. prescribing information when the drug was approved in 2021. Additional hepatotoxicity warnings and monitoring recommendations were added to the U.S. label in May this year.
In March, the FDA said its Adverse Event Reporting System contained 76 cases of drug-induced liver injury with reasonable evidence of a causal association with Tavneos. The agency reported that nearly all cases had serious outcomes, including 54 hospitalizations and eight deaths.
Alongside the clinical and safety data, Amgen argued that Tavneos remains an important treatment option for patients with severe active granulomatosis with polyangiitis and microscopic polyangiitis, the two main forms of AAV for which the drug is approved. The company cited patient perspectives describing challenges associated with available treatment approaches and noted that patients face difficult treatment tradeoffs with limited approved alternatives.
“Amgen strongly disagrees with the FDA’s proposal to withdraw Tavneos from the U.S. market,” the company said in a statement announcing the submission.
Amgen has formally requested an FDA hearing to defend Tavneos for the treatment of ANCA-associated vasculitis, following regulatory concerns surrounding the therapy. The move reflects Amgen’s commitment to preserving patient access to an important treatment option while addressing the agency’s questions with additional scientific evidence.
Why Amgen Requested the FDA Hearing
The FDA hearing request allows Amgen to present clinical data, safety findings, and expert opinions supporting Tavneos. The company believes the medicine continues to provide meaningful benefits for patients living with ANCA-associated vasculitis, a rare autoimmune disease that can severely damage blood vessels and vital organs.
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