By Christy Santhosh
June 26 (Reuters) – Europe’s drug regulator on Friday recommended revoking the marketing authorization for Amgen’s rare autoimmune disease medicine, citing concerns over the integrity of its trial data.
The European Medicines Agency’s recommendation is in line with the U.S. FDA’s proposal to withdraw the approval of Tavneos. The FDA identified 76 cases of drug-induced liver injury with evidence suggesting a causal link to the drug.
The EMA said the clinical study supporting Tavneos’ EU approval breached good clinical practice principles. It added that the data was found to be incorrect, misleading and no longer reliable for demonstrating the drug’s effectiveness.
The data collected after Tavneos was approved, along with additional analyses carried out after the main study, was 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.
The UK’s medicines regulator is investigating the drug, CSL told Reuters, adding that there has been no change to the UK marketing authorisation for Tavneos.
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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