A European medical committee has recommended approving a new medication called Lynavoy to treat severe itching in adults with a rare liver disease called primary biliary cholangitis (PBC). The European Commission is expected to make a final decision within the next few months. If approved, Lynavoy would become an important new option for patients struggling with this condition.
Primary biliary cholangitis is an autoimmune disease that damages the bile ducts in the liver. When bile can’t flow properly, bile acids build up in the body, causing intense itching, also known as cholestatic pruritus. This itching can be unbearable and often disrupts sleep, leads to extreme tiredness, and severely impacts a person’s quality of life. Over time, PBC can worsen and cause serious complications like cirrhosis, liver failure, or even the need for a liver transplant.
The recommendation to approve Lynavoy is based on strong evidence from a large clinical study called the GLISTEN phase 3 trial. In this study, patients who took Lynavoy experienced rapid, significant, and long-lasting relief from itching and the sleep problems it causes, compared to those who took a placebo (a fake treatment). The side effects seen in the study were similar to those reported in earlier research, and the medication works by blocking a specific pathway that contributes to the buildup of bile acids.
Francesco Balestrieri, CEO of Alfasigma (the company developing Lynavoy), shared his thoughts on the recommendation: “This positive opinion from the European medical committee is a major step forward for people living with PBC who suffer from severe itching. This symptom can be truly debilitating and dramatically affect daily life. We’re excited that Lynavoy could soon be available to patients in Europe, pending final approval and local access, as part of our mission to address complex health challenges in liver and immune-related diseases.”
He added: “Every day without effective treatment options for these patients is a day too long. This recommendation moves us closer to providing much-needed relief to those who need it most.”
Doctors often underdiagnose or overlook itching in PBC patients, even when symptoms are severe. Many people with significant itching do not receive treatment at all. Lynavoy offers hope for better symptom control and improved quality of life for those affected by this challenging disease.