The Italian Medicines Agency (AIFA) is making available an Important Safety Information Notice concerning Tavneos (avacopan), for which the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the revocation of the Marketing Authorisation in the European Union because the benefit-risk balance is no longer considered favourable.

This recommendation follows concerns regarding the reliability of the data from the pivotal ADVOCATE study, which can no longer be considered suitable for demonstrating the efficacy of the medicinal product, as well as additional concerns relating to hepatic safety.

Healthcare professionals are advised not to initiate treatment with Tavneos in new patients and to contact patients currently receiving treatment in order to evaluate treatment discontinuation and potential therapeutic alternatives.

Furthermore, in light of reports of additional cases of drug-induced liver injury (DILI) and vanishing bile duct syndrome (VBDS), including fatal cases, the requirements for liver function monitoring have been strengthened and should remain in place until treatment is discontinued.

Further information is provided in the related document.

Healthcare professionals are reminded of the importance of reporting suspected adverse reactions to ensure continuous monitoring of drug safety and the protection of patient health.