Full Breakdown
EMA Recommends Revoking Authorization for Amgen's Tavneos Over Data Integrity Concerns
6/27/2026, 12:30:11 AM
Regulatory Recommendation to Revoke Tavneos Authorization
On 26 June 2026, the European Medicines Agency (EMA) recommended that the European Commission revoke the marketing authorization for Tavneos (avacopan), a treatment for anti-neutrophil cytoplasmic autoantibody-associated vasculitis (AAV). The EMA’s Committee for Medicinal Products for Human Use advised that no new patients be started on the drug and that existing patients be switched to suitable alternatives. The recommendation follows a parallel proposal by the U.S. Food and Drug Administration (FDA) to withdraw Tavneos from the U.S. market.
Background & Context
Tavneos received EU approval in 2022 based on the pivotal ADVOCATE trial, which enrolled 331 adults with severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). The drug, a complement 5a receptor blocker, was shown to be at least as effective as high-dose corticosteroids in inducing remission and to improve long-term remission rates. Amgen markets the drug in partnership with CSL Vifor in Europe. The FDA later identified 76 cases of drug-induced liver injury linked to Tavneos, prompting its withdrawal proposal.
Data & Statistics
- ADVOCATE trial participants: 331 patients received a 52-week course of avacopan or placebo alongside standard therapy.
- FDA safety signal: 76 reported cases of drug-induced liver injury, with evidence suggesting a causal relationship.
- Rare disease focus: Tavneos treats GPA and MPA, two rare inflammatory vasculitides affecting small- to medium-sized blood vessels.
- Additional safety concerns: The EMA highlighted risk of vanishing bile duct syndrome (VBDS), a rare condition involving progressive loss of intra-hepatic bile ducts.
Official Statements & Responses
- Amgen: Expressed that it is “deeply concerned” about the EMA recommendation but “continues to believe that Tavneos is an important treatment option for people living with AAV.” The company noted that CSL Vifor is leading discussions with the EMA on next steps for patients and healthcare providers.
- CSL Vifor: Confirmed its role in liaising with regulators and overseeing patient transition plans.
- FDA: Extended the deadline for Amgen to submit additional data to 29 July 2026, reflecting ongoing review.
- UK regulator: Launched an investigation into Tavneos but has not altered the drug’s marketing authorization in the United Kingdom.
Criticism & Opposition
The EMA’s assessment identified “breaches of good clinical practice” in the ADVOCATE trial, describing the submitted data as “incorrect, misleading and no longer reliable” for demonstrating efficacy. The agency concluded that the drug’s benefits no longer outweigh its risks, citing the liver-injury signal and the potential for VBDS. These findings form the basis of the regulator’s opposition to continued use of Tavneos in the EU.
Conflicting Reports & Gaps
- The UK Medicines and Healthcare products Regulatory Agency (MHRA) continues to allow Tavneos on the market, contrasting with the EMA’s recommendation.
- The FDA’s extended deadline indicates that additional data may still be forthcoming, creating uncertainty about the final outcome in the United States.
Verbatim Quotes
- “continues ?to believe that Tavneos is an important treatment option for people living with AAV.” — Amgen spokesperson
- “The EMA's Committee for Medicinal Products for Human Use has recommended that no new patients should start treatment with Tavneos, while existing patients should be switched to suitable alternatives.” — EMA Committee for Medicinal Products for Human Use
- “It added that the data was found to be incorrect, misleading and no longer reliable for demonstrating the drug's effectiveness.” — EMA
- “The European Medicines Agency (EMA) has recommended revoking the marketing authorization for Tavneos (avacopan, ChemoCentryx) in the European Union because its benefits are no longer proven to outweigh its risks.” — EMA
- “Due to “breaches of good clinical practice,” the EMA said that data from this pivotal trial could no longer be relied upon to demonstrate the medicine’s efficacy.” — EMA
- “If VBDS is suspected, Tavneos should be discontinued immediately.” — EMA
What’s Next
The EMA’s opinion will be forwarded to the European Commission, which will issue a final, binding decision applicable across all EU member states. If confirmed, Tavneos will lose its EU authorization, requiring patients to transition to alternative therapies. Concurrently, the FDA will review the additional data Amgen submits before its July 29 deadline, determining the drug’s fate in the United States. Healthcare providers in Europe are advised to monitor liver function closely and to prepare for potential treatment changes.
