European regulator calls for Amgen’s Tavneos to lose its marketing authorization

EMA recommends revocation

The European Medicines Agency’s human medicines committee has recommended revoking Tavneos’s marketing authorization in the European Union, a major setback for Amgen’s rare-disease drug.

The recommendation, announced on June 26, 2026, does not immediately remove the medicine from the market. The European Commission must still decide whether to follow the committee’s advice and make the change final.

Tavneos is sold in Europe by CSL’s Vifor business and is used to treat adults with granulomatosis with polyangiitis and microscopic polyangiitis, two forms of ANCA-associated vasculitis.

Why regulators moved

The EMA said the review was triggered by information that raised questions about the data integrity of the main study used to support Tavneos’s EU approval.

After reviewing the evidence, the Committee for Medicinal Products for Human Use concluded that the study was in breach of good clinical practice and that the data were incorrect, misleading and could not be relied upon.

That finding goes beyond a routine safety update. It means the regulator believes the core evidence package behind the medicine’s European approval is not dependable.

The committee also said Tavneos’s benefits are no longer proven to outweigh its risks for the approved patient population.

What the recommendation means for patients

The committee recommended that no new patients start Tavneos in the EU and that current patients be switched to suitable alternatives.

That raises immediate practical questions for clinicians and patients in a disease area where treatment options are limited and the condition can be life-threatening.

The recommendation also puts pressure on the European Commission, which will have to weigh the committee’s assessment before any authorization change becomes final.

The chronology of scrutiny

Tavneos was originally approved in the European Union in January 2022.

The EMA began reviewing the drug in January 2026 after concerns emerged over the data behind the approval package.

The European action now follows months of wider scrutiny of the medicine’s safety profile, including liver-injury signals in other markets.

In March 2026, the U.S. Food and Drug Administration said it had identified 76 cases of drug-induced liver injury linked to Tavneos, including eight deaths and 54 hospitalizations. The FDA said the reports represented new safety concerns.

The FDA had asked Amgen in January 2026 to voluntarily withdraw Tavneos from the U.S. market, and Amgen refused.

Wider safety concerns

The European recommendation also comes after developments in Japan.

In May 2026, Kissei Pharmaceutical said 20 people in Japan had died and at least 22 had developed serious liver injury after taking Tavneos, and it told doctors to stop prescribing it to new patients.

Those reports do not by themselves determine the EU case, but they add to the broader pressure on the drug and on the companies involved.

What happens next

The immediate next step is a decision by the European Commission on whether to adopt the EMA committee’s recommendation.

Amgen and CSL can still respond publicly as the process continues, and the final outcome in Europe is not yet locked in.

If the recommendation is adopted, clinicians in Europe would need to move existing patients to alternative treatments and stop starting new ones on Tavneos.

The drug also remains under parallel pressure in the United States, where the FDA withdrawal process is still active.

Why it matters

Tavneos is used in a rare autoimmune disease setting where the available treatment options are limited and the stakes are high for affected patients.

The case is also notable because the European action is based not only on safety scrutiny but on concerns that the key supporting study cannot be trusted.

Taken together, the European recommendation, the U.S. liver-safety findings and the Japanese reports leave Tavneos facing one of the most serious regulatory challenges of any Amgen medicine this year.