European Regulator Calls for Amgen's Tavneos to Have Authorization Revoked
By Dean Seal
The European Medicines Agency has called for Amgen's Tavneos, a medication for two rare inflammatory conditions of the blood vessels, to have its marketing authorization revoked.
The regulator said Friday that its human-medicines committee has reviewed the medicine and found that its benefits are no longer proven to outweigh the risks in treating adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis.
The review was kicked off after the agency received information that raised questions about the data integrity of the main study that supported Tavneos getting marketing authorization in the first place.
The regulator's Committee for Medicinal Products for Human Use concluded that the main study was in breach of good clinical practice principles, with study data found to be incorrect, misleading and unable to be relied upon.
The decision to call for the authorization to be revoked in the European Union was supported by the views of patient and healthcare-professional representatives, and by written interventions received from third parties, the regulator said.
The committee is recommending that no new patients start treatment with Tavneos and that existing patients be switched to suitable alternatives. The recommendation will now be considered by the European Commission.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
June 26, 2026 08:01 ET (12:01 GMT)
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