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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📍 How it ended
European regulators and the CHMP recommended revoking the marketing authorization for Amgen's Tavneos after study data was found unreliable. Simultaneously, the FDA pursued efforts to pull the drug over alleged data manipulation.
Epilogue added 10d ago, after coverage quieted.
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 20d 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 (8)
- Latest CHMP decisions led by recommendation to revoke approval of Tavneos FirstWord Pharma · 21d ago
- CSL Faces EU Withdrawal Of Tavneos After EMA Finds Study Data Unreliable Citeline News & Insights · 21d ago
- Inside FDA’s Effort to Pull an Amgen Drug Over Alleged Data Manipulation Bloomberg · 21d ago
- New Data Lead to Decision to Revoke Autoimmune Disease Drug Medscape · 21d ago
- Europe's CHMP reverses endorsement of Tavneos as Amgen FDA hearing looms Fierce Pharma · 21d ago
- EU regulators recommend revoking the marketing authorization for Amgen’s Tavneos Endpoints News · 21d ago
- EU regulator backs revoking Amgen's right to sell rare-disease drug Reuters · 21d ago
- European Regulator Calls for Amgen’s Tavneos to Have Authorization Revoked WSJ · 21d ago
Topics
From around our network
- What Is a 'Gold Card'? The Rule That Skips Prior Authorization daybreakwire.com
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