Europe’s leading medicines authority announced Friday that it is recommending the removal of Amgen’s drug Tavneos from the market, determining that the treatment’s potential benefits do not justify the risks it poses to patients.
The European Medicines Agency made the recommendation after concerns about the drug’s safety profile mounted. Earlier, in April, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research had already proposed pulling its own approval of Tavneos, following the identification of 76 cases of drug-induced liver injury — with evidence pointing to the drug as the likely cause.
Tavneos is used to treat anti-neutrophil cytoplasmic autoantibody-associated vasculitis, an uncommon category of autoimmune disorders that trigger dangerous inflammation in small- to medium-sized blood vessels throughout the body.
The EMA’s Committee for Medicinal Products for Human Use issued guidance stating that no new patients should begin taking Tavneos. For those already on the medication, the committee recommends transitioning to appropriate alternative therapies.
