Rome, 10 September (Adnkronos Salute) – “With my conscience and sensitivity as a doctor, I am close to patients with primary biliary cholangitis (PBC), a rare liver disease, for whom obeticholic acid risks no longer being available in Italy and throughout Europe. We are talking about a therapeutic possibility that is now lacking on the basis of a clinical study criticized by many for a series of biases that make it unreliable. For this reason, I have presented a question to the Ministry of Health in the Senate”. This was stated by Senator Ignazio Zullo (Brothers of Italy), member of the 10th Commission of the Senate of the Republic, speaking this morning in Rome – close to World PBC Awareness Day, which was celebrated on 8 September – at a meeting with the press organized by Omar, Observatory of Rare Diseases, in collaboration with Amaf Aps Ets – Association of Autoimmune Liver Diseases and Association EpaC Ets and with the unconditional contribution of Advanz Pharma.
The aim of the question “is to understand whether it is possible to activate that regulatory article that allows at least the continuation of treatment with obeticholic acid in subjects who are already undergoing treatment – explained Zullo – and while waiting for a review and reformulation of the study that led to this exit of patients who were doing better with the drug and who fear being in the placebo branch”.
The hope “is that this question will have a positive outcome and that patients with CBP can continue treatment because the harmful effects of this pathology”, including cirrhosis and liver failure, “we cannot afford them either for health reasons or for costs that we then have to sustain as a National Health Service. I am however alongside you” not only patients “to lead and carry forward this battle”, he concluded.