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.
Tavneos treats anti-neutrophil cytoplasmic autoantibody-associated vasculitis, a rare group of autoimmune diseases that cause inflammation in small- to medium-sized blood vessels.
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.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shreya Biswas)
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