GLI Celebrates FDA Approval of Livdelzi®, an Option in Personalizing PBC Treatment
(Washington, D.C. August 14, 2024) – Global Liver Institute (GLI) celebrates the expansion of treatment options for patients with primary biliary cholangitis (PBC) after the U.S. Food and Drug Administration decided to provide accelerated approval of Gilead Science’s seladelpar (Livdelzi®) for primary biliary cholangitis (PBC). This new treatment serves as a second-line option for the almost 40% of patients who do not achieve adequate response with ursodeoxycholic acid (UDCA) alone and can be used in conjunction with UDCA.
Livdelzi® stands out in the therapeutic landscape for its unique ability to address multiple aspects of PBC with a single medication. For many patients, managing PBC involves having to juggle treatments for alleviating symptoms and/or improving disease progression. Livdelzi® effectively bridges this gap by providing comprehensive benefits. It not only enhances liver function markers, such as fibrosis and ALP scores, but it also alleviates common and debilitating symptoms such as pruritus (chronic itch) and fatigue.
The approval provides flexibility for patients who do not tolerate UDCA or do not respond to it, as Livdelzi® has been approved to be administered alone or in combination with UDCA. GLI’s Program Director of Pediatric and Rare Liver Diseases Kristin Hatcher notes, “This flexibility ensures that patients have access to a treatment that aligns with their individual needs and preferences, a significant advancement in personalized care for PBC.”
GLI celebrates this achievement with the PBC community and recognizes it as a testament to the progress being made in liver disease treatment. The approval of Livdelzi® not only expands the treatment options available to PBC patients but also exemplifies the transformative impact of collaborative scientific efforts.
About Global Liver Institute
Global Liver Institute (GLI) is a 501(c)3 nonprofit organization founded in the belief that liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. Operating globally, GLI is committed to solving the problems that matter to liver patients and equipping advocates to improve the lives of individuals and families impacted by liver disease. GLI holds Platinum Transparency with Candid/GuideStar, is a member of the National Health Council, and serves as a Healthy People 2030 Champion. Follow GLI on Facebook, Instagram, LinkedIn, and YouTube or visit www.globalliver.org.