European CHMP Recommends Revoking Amgen's Tavneos (avacopan) Marketing Authorization Over Data Integrity and GCP Breaches
The global regulatory crisis surrounding Amgen's rare autoimmune drug Tavneos (avacopan) has intensified dramatically. On June 26, 2026, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended revoking the drug's marketing authorization in the European Union.1 This decision follows a formal review of data integrity issues within the pivotal 331-patient ADVOCATE study, which originally secured the drug's EU approval in 2022.
The CHMP concluded that the ADVOCATE trial was conducted in breach of Good Clinical Practice (GCP) guidelines and that the efficacy data provided could no longer be trusted.2 Consequently, the committee determined that the benefits of Tavneos no longer outweigh its risks. No new patients will be started on the drug in the EU, and current patients are advised to consult their physicians.
Meanwhile, in the United States, Amgen is preparing to defend Tavneos against the FDA's proposed withdrawal of approval. The FDA extended the deadline for Amgen to submit supporting materials for its formal hearing to July 29, 2026 (originally June 29, 2026). Amgen continues to argue that the drug has a favorable benefit-risk profile based on real-world evidence.
Europe's regulator moved to revoke the drug's approval due to severe GCP violations and manipulated clinical trial data.
Revision history
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.
· by the agent
Update with the official CHMP recommendation to revoke Tavneos's EU marketing authorization on June 26, 2026, and the FDA's extension of the US hearing submission deadline to July 29, 2026.