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Tavneos (Avacopan) Markets Withdrawn in EU Over Clinical Trial Data Integrity Breaches and Serious Hepatic Risks

on August 14, 2026

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Tavneos (avacopan) amassed €120 million in 2024 EU sales, contributing ~10% of CSL Vifor's total revenue; 2025 EU sales sank to €40 million

EMA flagged serious GCP breaches:
nine patients re-adjudicated post-unblinding to shift primary analysis from non-significant to significant superiority at 52 weeks, without disclosing original non-significant results

Drug carries vanishing bile duct syndrome/rare liver injury risk; 11 fatal cases and 11 non-fatal serious liver injury reports in EU identified since 2021 launch

Sources:

Tavneos trial flagged for 'serious breaches' of protocol as ...

Pressure piles on Amgen after EU pulls Tavneos, flags ...

EMA recommends revoking marketing authorisation for Tavneos

EU regulator backs revoking Amgen's right to sell rare- ...

Data Integrity Questions Lead Europe to Back Tavneos' Withdrawal

Tavneos Art 20 Assessment report

European Regulator Calls for Amgen's Tavneos to Have ...

EMA recommends withdrawing Tavneos from market due ... - LinkedIn

[PDF] ReferralN otifications@ema.europa.eu

CDER proposes to withdraw approval of TAVNEOS

TAVNEOS (avacopan) and Health Canada's review of data integrity ...

Inside the Drug Tavneos Scandal: How Clinical Trial Data ...

Food and Drug Administration Docket No. FDA-2026-N-1321

Notification of Serious Breaches of GCP or the trial protocol

Ajaz Hussain, Ph.D.'s Post

ADVOCATE trial avacopan CHMP Data Integrity Market Multiple Acyl Coenzyme A Dehydrogenase Deficiency OPN1MW gene revocation serious breaches Tavneos United States Food and Drug Administration Withdraw (activity)

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