European Medicines Agency Recommends Revoking Amgen's Tavneos Over Data Integrity Issues

The European Medicines Agency recommends revoking marketing authorization for Amgen's rare disease drug, Tavneos, after finding its supporting clinical data was incorrect, misleading, and unreliable. The move follows a U.S. FDA proposal to withdraw the drug due to 76 cases of liver injury. Amgen, which acquired Tavneos's developer for $3.7 billion, is "deeply concerned" and is reviewing data for the FDA.

EMA marketing authorisation revocation

• ▪The EMA advised that no new patients should start treatment with Tavneos and that current patients should be switched to suitable alternatives
• ▪The EMA's human-medicines committee concluded that the benefits of Tavneos are no longer proven to outweigh its risks
• ▪The European Medicines Agency (EMA) recommended on June 26, 2026, that the marketing authorization for Amgen's drug, Tavneos, be revoked

Data integrity violations

• ▪The EMA determined the clinical study supporting Tavneos's EU approval breached good clinical practice principles
• ▪The data from the clinical study was found to be incorrect, misleading, and unreliable for demonstrating the drug's effectiveness
• ▪Scrutiny of Tavneos began after allegations of data manipulation in its clinical trial emerged in the previous year

FDA liver injury concerns

• ▪In April, the U.S. FDA's Center for Drug Evaluation and Research proposed withdrawing its approval of Tavneos
• ▪The FDA's proposal was based on 76 identified cases of drug-induced liver injury with evidence suggesting a causal link to Tavneos

Tavneos clinical profile

• ▪The drug was approved for use in the European Union in 2022
• ▪Tavneos was originally developed by ChemoCentryx, which Amgen later acquired for $3.7 billion
• ▪Tavneos treats anti-neutrophil cytoplasmic autoantibody-associated vasculitis (AAV), a rare autoimmune disease causing inflammation in blood vessels

Amgen response strategy

• ▪Amgen stated it was "deeply concerned" about the EMA's recommendation and that it "continues to believe that Tavneos is an important treatment option."
• ▪The deadline for Amgen to submit its reviewed data to the FDA has been extended to July 29 from June 29
• ▪Amgen has hired a research firm to conduct an independent review of the Tavneos data for a hearing with the FDA
• ▪Amgen's partner in Europe, CSL Vifor, is leading interactions with the EMA regarding next steps for patients and providers