The European Medicines Agency has recommended revoking the marketing authorization for Amgen's Tavneos, a drug used to treat two rare inflammatory conditions affecting blood vessels. This decision follows a review by the agency's human-medicines committee, which concluded that the medication's benefits no longer outweigh its risks.

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https://www.wsj.com/health/pharma/european-regulator-calls-for-amgens-tavneos-to-have-authorization-revoked-b3922308

European Regulator Calls for Amgen’s Tavneos to Have Authorization Revoked

The agency received information that raised questions about the data integrity of the study that supported Tavneos getting marketing authorization

Dean Seal

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An Amgen sign on an office building, with an American flag flying in the foreground. 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.robert galbraith/Reuters

The European Medicines Agency has called for Tavneos, a medication owned by Amgen and licensed in Europe by CSL’s Vifor, 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 two rare inflammatory conditions of the blood vessels.

European Regulator Calls for Amgen’s Tavneos to Have Authorization Revoked

European Regulator Calls for Amgen’s Tavneos to Have Authorization Revoked

The agency received information that raised questions about the data integrity of the study that supported Tavneos getting marketing authorization

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