Pirro (M5S): “On therapy for primary biliary cholangitis, dialogue with the Ministry of Health and Aifa”

: On the issue of obeticholic acid, a treatment used for years to control the progression of primary biliary cholangitis (PBC), a rare liver disease that mainly affects women, and which risks no longer being available to patients throughout Europe, “there is maximum attention from politics and institutions. The situation is quite complex, which is why we have presented several questions to the Senate and the Chamber and started informal dialogues with the Ministry of Health and the Italian Medicines Agency, to urge actions to protect patients”. This was stated by Senator Elisa Pirro, Commission X Social Affairs, Health, Public and Private Employment, Social Security of the Senate, speaking this morning in Rome – close to the World PBC Awareness Day, which was celebrated on 8 September – at a press conference organized by Omar, Observatory of Rare Diseases, in collaboration with Amaf Aps Ets – Association of Autoimmune Liver Diseases and Associazione EpaC Ets, with the unconditional contribution of Advanz Pharma.

“AIFA has promptly acknowledged not the withdrawal of the treatment from the market – Pirro assured – but the decision of the European Court to freeze the EMA’s decision on the withdrawal from the market. Therefore, at this time, Italian patients can continue to purchase the drug, in other words to find it in pharmacies, as they have done up to now”. However, “the situation of the European Court is a complicated situation, because there are many concerns among patients and the clinicians who are treating them. For these reasons, we are also having discussions with our MEP colleagues, in order to raise the issue not only at a national level, but also at the level of the European Parliament. Therefore, everyone is paying maximum attention to the issue and we are all doing our best to ensure that there are no problems relating to the health of citizens and patients who take the drug”, he concluded.