European Regulator Calls for Amgen’s Tavneos to Have Authorization Revoked
European regulators are recommending the revocation of marketing authorization for Amgen's autoimmune disease drug, Tavneos.
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The brief
The Committee for Medicinal Products for Human Use (CHMP) has reversed its endorsement of Tavneos. This recommendation would revoke Amgen's right to sell the rare-disease drug within the European market.
Coverage from Reuters, WSJ, Endpoints News, Fierce Pharma, and Medscape emphasizes that the decision follows the emergence of new data. The move comes as Amgen faces an upcoming hearing with the FDA.
Attention now turns to the outcome of the FDA hearing and the final implementation of the CHMP's recommendation regarding the drug's authorization.
Synthesized by Archynetys from the headlines below under a strict no-invention contract. ✓ fact-checked: all claims supported by sources Updated 2h ago.
Quick answers
What drug is affected by the regulator's decision?
Tavneos, a drug developed by Amgen for autoimmune and rare diseases.
Why is the authorization being revoked?
According to Medscape, the decision was led by new data.
Which regulatory body issued the recommendation?
The CHMP (Committee for Medicinal Products for Human Use) in Europe.
Coverage (5)
- New Data Lead to Decision to Revoke Autoimmune Disease Drug Medscape · 7h ago
- Europe's CHMP reverses endorsement of Tavneos as Amgen FDA hearing looms Fierce Pharma · 7h ago
- EU regulators recommend revoking the marketing authorization for Amgen’s Tavneos Endpoints News · 7h ago
- EU regulator backs revoking Amgen's right to sell rare-disease drug Reuters · 7h ago
- European Regulator Calls for Amgen’s Tavneos to Have Authorization Revoked WSJ · 7h ago
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