Amgen has submitted a comprehensive data package to the FDA to support its request for a hearing aimed at preserving the U.S. approval of Tavneos (avacopan), its rare-disease drug for ANCA-associated vasculitis.
The package includes a third-party re-evaluation of the pivotal ADVOCATE trial by the Duke Clinical Research Institute, which confirmed noninferiority versus prednisone taper at Weeks 26 and 52, although it did not reproduce the original superiority finding at 52 weeks.
Amgen also submitted real-world evidence, safety analyses, and patient and clinician testimonials, arguing that Tavneos remains a vital treatment option for patients with severe AAV who face limited and burdensome alternatives.
This move follows the FDA's April 2026 proposal to withdraw Tavneos over concerns about trial data integrity (potential manipulation of endpoint adjudications) and lack of proven effectiveness, as well as post-marketing signals of serious liver injury.
Amgen has refused the FDA's request for voluntary withdrawal, continues to market Tavneos in the U.S., and is pushing for a formal hearing where it will present the full benefit–risk dossier and patient perspectives before any final withdrawal decision.
Sources:
Amgen hands in data package in hopes of FDA hearing for ...
Amgen Defends Rare Disease Drug in FDA Crosshairs
Amgen Statement on FDA Data Submission for TAVNEOS ...
Letter NOOH Taveneos (avacopan)
Amgen submits new data to challenge FDA's proposal to withdraw Tavneos
Amgen continues to defend Tavneos as global regulatory pressure mounts
Amgen Seeks FDA Hearing To Challenge Proposed ...
An Important Update Regarding TAVNEOS® (avacopan)
Amgen Defends Tavneos' FDA Approval for ANCA-Vasculitis with ...
EMA recommends revoking marketing authorisation for Amgen's rare-disease drug
FDA proposes to withdraw Amgen's rare autoimmune disease drug
Amgen Reevaluates Tavneos Data as Drug Faces FDA Scrutiny
Amgen Will Not Heed FDA Request To Withdraw Rare ...
Amgen Seeks FDA Hearing To Challenge Proposed Tavneos Withdrawal