What specific concerns led the European Medicines Agency to recommend revoking Amgen's Tavneos marketing authorization?

The European Medicines Agency (EMA) recommended revoking the marketing authorization for Tavneos because the clinical study supporting its 2022 EU approval breached good clinical practice principles, and the data was found to be 'incorrect, misleading and no longer reliable for demonstrating the drug's effectiveness'; additionally, post-approval data and further analyses were deemed insufficient to prove the medicine's benefits.

What immediate regulatory actions has the EMA proposed for patients currently using or considering Tavneos in the EU?

The EMA's Committee for Medicinal Products for Human Use recommended that no new patients should start treatment with Tavneos, while existing patients should be switched to suitable alternatives.

EU Regulator Backs Revoking Amgen's Right to Sell Rare-Disease Drug

Jun 26, 2026

The European Medicines Agency recommended revoking Amgen's marketing authorization for its rare-disease drug Tavneos due to unreliable clinical trial data. This aligns with a similar FDA proposal, prompting Amgen to commission an independent data review before a hearing.

reuters

2026-06-26

EU Regulator Backs Revoking Amgen's Right to Sell Rare-Disease Drug

EU Regulator Backs Revoking Amgen's Right to Sell Rare-Disease Drug

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