By Christy Santhosh
June 26 (Reuters) – The European Medicines Agency on Friday recommended revoking the marketing authorisation for Amgen’s rare autoimmune disease drug, Tavneos, citing a lack of benefits that outweigh its risks.
In April, the U.S. FDA’s Center for Drug Evaluation and Research had proposed withdrawing approval of Tavneos, after identifying 76 cases of drug-induced liver injury with evidence suggesting a causal link to the drug.
The EMA said the clinical study supporting the medicine’s EU approval breached good clinical practice principles and the data were found to be incorrect, misleading and no longer reliable for demonstrating Tavneos’ effectiveness.
The data collected after the drug was approved, along with additional analyses carried out after the main study, were not enough to prove the medicine’s benefits, the EMA said.
Tavneos, approved in 2022 in the EU, treats anti-neutrophil cytoplasmic autoantibody-associated vasculitis, a rare group of autoimmune diseases that cause inflammation in small- to medium-sized blood vessels.
Amgen said in a statement it was “deeply concerned” about the potential impact of the recommendation and that it “continues to believe that Tavneos is an important treatment option for people living with AAV.”
The company said CSL Vifor, its partner in Europe, is leading interactions with the EMA regarding the next steps for patients and healthcare providers in Europe.
The EMA’s Committee for Medicinal Products for Human Use has recommended that no new patients should start treatment with Tavneos, while existing patients should be switched to suitable alternatives.
Amgen has signed up a research firm to independently review the data on Tavneos, as it seeks to prove the drug’s benefits before a hearing with the FDA.
The drugmaker said the deadline for submitting the data to the FDA has been extended to July 29 from June 29.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shreya Biswas)
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