BOLOGNA (ITALPRESS) – The Human Use Medicines Committee (CHMP – Committee for Medicinal Products for Human Use) of the European Agency for Medicinal Products (EMA) has expressed favourable opinion, recommending approval in the European Union of linerixibat for the treatment of cholestatic itching in adult patients suffering from primitive biliary cholangitis (CBP). The final decision of the European Commission is expected in the coming months. Cholestatic itching is a common and highly invalidating symptom that affects up to 89% of people suffering from CBP, a rare autoimmune liver disease that can evolve in cirrhosis, liver failure and make liver transplant necessary. This symptom severely impairs the quality of patient life, causing chronic sleeping disorders and fatigue. The positive opinion of the CHMP is based on the positive results of Phase III GLISTEN study. GLISTEN has reached the primary endpoint and the main secondary endpoints, demonstrating a rapid, significant and sustained improvement of cholestatic itching and the interference of sleep itching compared to placebo. The linerixibat safety profile was consistent with previous studies and with the IBAT inhibition mechanism.“The favourable opinion of the CHMP for linerixibat is a key milestone for people with primitive biliary colangitis suffering from cholestatic itching, a debilitating symptom, which can seriously impact the quality of life – says Francesco Balestrieri, CEO of Alfasigma. This recommendation brings us closer to the goal of making available a new therapeutic option for eligible patients – subject to regulatory approval and local access paths – and supports Alfasigma’s strategy to consolidate its business in specialist care and rare diseases, facing complex health challenges in gastroenterology and immunology.” In PBC, a cholestatic liver disease, the bile flow from the liver is altered. The excess of biliary acids in the circle resulting from it causes cholestatic itching, that is a feeling of internal itching that cannot be relieved scratching. Itching may occur at any stage of the PBC or regardless of the biochemical control of the disease. This is a serious condition that can be debilitating: patients can present sleeping disorders, fatigue, reduction of quality of life and sometimes require liver transplantation even in the absence of liver failure.The data from the United States indicate that itching is often not documented in clinical records and that up to a third of patients with clinically significant itching does not receive any treatment. Linerixibat is an IBAT inhibitor that reduces itching mediators in circulation. Following the licensing agreement with GSK plc, Alfasigma has acquired exclusive rights globally for the development, production and marketing of linerixibat.Linerixibat has already been approved in the United States and the United Kingdom.
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