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Patients should not pay for failure in science
Vasculitis International has published its position statement on the ongoing regulatory review of TAVNEOS® (avacopan) — and warns that data integrity and risk/benefit analysis are two very different issues and must not be treated as one, when taking action. Otherwise the patient pays for science failure.
Update Tavneos® April 29th 2026
The FDA has moved from a review to a formal proposal to withdraw approval of Tavneos in the United States.
This is a more serious step than a review, but it is still not a final decision.
In Europe, the EMA review is still ongoing. No conclusions have been reached yet, and Tavneos is still available.
Update Tavneos Review – April 2026
The U.S. Food and Drug Administration (FDA) issued a Drug Safety
Communication on 31 March 2026, alerting healthcare professionals and patients to serious cases of drug-induced liver injury (DILI) in postmarketing surveillance of avacopan — including cases with fatal outcomes.
While the FDA operates outside the European regulatory framework,
its postmarketing findings are directly relevant to the EMA’s ongoing assessment.
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