European Regulator Calls for Amgen’s Tavneos to Have Authorization Revoked
EU regulators propose removing Amgen’s Tavneos from market amid new safety concerns
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The brief
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended revoking the marketing authorization for Amgen’s Tavneos, a drug used to treat autoimmune diseases. The decision follows the emergence of new data raising safety concerns, though specifics have not been disclosed. Coverage from Reuters, WSJ, Medscape, Fierce Pharma, and Endpoints News highlights the CHMP’s reversal of its earlier endorsement, signaling a shift in regulatory stance.
The move comes as Tavneos remains under scrutiny, with the FDA hearing looming as a critical next step for Amgen’s defense of the drug. Watch for Amgen’s response to the CHMP’s recommendation, including any plans to appeal or withdraw the drug voluntarily. The FDA hearing will be closely watched for potential parallels in regulatory action.
Patients and clinicians may also seek guidance on alternative treatments as Tavneos’ availability becomes uncertain.
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Quick answers
What is Tavneos used to treat?
Tavneos is an autoimmune disease drug, though coverage does not specify exact conditions.
Why is the EU revoking its authorization?
The CHMP cites new data raising safety concerns, but details remain undisclosed.
Will this affect Tavneos’ availability in the U.S.?
The FDA is holding a hearing on Tavneos, but no decision has been made. The EU’s action may influence the outcome.
Coverage (5)
- New Data Lead to Decision to Revoke Autoimmune Disease Drug Medscape · 9h ago
- Europe's CHMP reverses endorsement of Tavneos as Amgen FDA hearing looms Fierce Pharma · 9h ago
- EU regulators recommend revoking the marketing authorization for Amgen’s Tavneos Endpoints News · 9h ago
- EU regulator backs revoking Amgen's right to sell rare-disease drug Reuters · 9h ago
- European Regulator Calls for Amgen’s Tavneos to Have Authorization Revoked WSJ · 9h ago
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