Reuters

Medical journal retracts paper on Amgen’s Tavneos drug trial after FDA findings

NEJM

Retraction: Jayne DRW et al. Avacopan for the Treatment of ANCA-Associated Vasculitis, N Engl J Med 2021;384:599-609.

U.S. Food and Drug Administration

CDER proposes to withdraw approval of TAVNEOS

Letter NOOH Taveneos (avacopan)

European Medicines Agency (EMA)

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2026

Amgen

An Important Update Regarding TAVNEOS® (avacopan)

EMA recommends revoking marketing authorisation for Tavneos

Fierce Pharma

FDA hearing on Amgen's Tavneos will include findings from an independent review

BioSpace

Amgen shores up Tavneos FDA defense with Duke data analysis

Bloomberg

Amgen Drug Tavneos’ Main Study Retracted by Medical Journal

The New England Journal of Medicine retracted a 2021 study on Amgen's Tavneos after an FDA investigation found that primary endpoint data for nine patients were altered following database lock and trial unblinding, and that these changes were not disclosed in the article.

The New England Journal of Medicine retracted a 2021 study on Amgen's Tavneos after an FDA investigation found that primary endpoint data for nine patients were altered following database lock and trial unblinding, and that these changes were not disclosed in the article.

The FDA's Center for Drug Evaluation and Research proposed in April to withdraw Tavneos from the market, citing a lack of substantial evidence of effectiveness and untrue statements of material fact in the original approval application submitted by ChemoCentryx, a wholly owned Amgen subsidiary.

The FDA's Center for Drug Evaluation and Research proposed in April to withdraw Tavneos from the market, citing a lack of substantial evidence of effectiveness and untrue statements of material fact in the original approval application submitted by ChemoCentryx, a wholly owned Amgen subsidiary.

Europe's medicines committee recommended revoking Tavneos' EU marketing authorization after concluding the Advocate study was conducted in breach of good clinical practice principles, with study data found to be incorrect and misleading.

Europe's medicines committee recommended revoking Tavneos' EU marketing authorization after concluding the Advocate study was conducted in breach of good clinical practice principles, with study data found to be incorrect and misleading.

The FDA identified 76 cases of drug-induced liver injury with reasonable evidence of a causal link to Tavneos between its 2021 approval and October 2024, including seven biopsy-confirmed cases of vanishing bile duct syndrome and eight deaths.

The FDA identified 76 cases of drug-induced liver injury with reasonable evidence of a causal link to Tavneos between its 2021 approval and October 2024, including seven biopsy-confirmed cases of vanishing bile duct syndrome and eight deaths.

Amgen engaged the Duke Clinical Research Institute in February to independently review data from the phase 3 Advocate study, with findings to be submitted to the FDA by July 29 as part of a hearing request to keep Tavneos on the market.

Amgen engaged the Duke Clinical Research Institute in February to independently review data from the phase 3 Advocate study, with findings to be submitted to the FDA by July 29 as part of a hearing request to keep Tavneos on the market.

Amgen said it remains confident in Tavneos' benefit-risk profile, citing more than 23 real-world studies involving over 1,200 patients, while noting the drug recorded $462 million in sales in 2025 before first-quarter 2026 sales fell 22% sequentially to $119 million.

Amgen said it remains confident in Tavneos' benefit-risk profile, citing more than 23 real-world studies involving over 1,200 patients, while noting the drug recorded $462 million in sales in 2025 before first-quarter 2026 sales fell 22% sequentially to $119 million.

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BioSpace #

Bloomberg #

Medical journal retracts paper on Amgen’s Tavneos drug trial after FDA findings

Medicine & healthcare

FDA Moves to Pull Amgen's Tavneos Over Data Fraud

FDA Moves to Pull Amgen's Tavneos Over Data Fraud

MedicalFDA journalMoves retractsto paperPull on Amgen’'s Tavneos drugOver trialData after FDA findingsFraud

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FDA Moves to Pull Amgen's Tavneos Over Data Fraud

MedicalFDA journalMoves retractsto paperPull on Amgen’'s Tavneos drugOver trialData after FDA findingsFraud

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