Global Liver Institute Acknowledges FDA Request for Further Studies as Obeticholic Acid Remains Available for PBC Patients

(Washington, D.C. November 12, 2024) – Global Liver Institute (GLI) acknowledges the U.S. Food and Drug Administration’s (FDA) decision today to issue a Complete Response Letter (CRL) for the supplemental New Drug Application (sNDA) of obeticholic acid (OCA, OCALIVA®) for primary biliary cholangitis (PBC). This determination means that while the FDA is unable to approve the sNDA and cannot provide full approval at this time, obeticholic acid will remain available to patients under its accelerated approval status until a final decision can be made.

The FDA’s requirement for further clinical data highlights the importance of fully validating the long-term safety and efficacy of OCA for PBC patients. We encourage Intercept Pharmaceuticals to engage patients throughout the process of developing new research that best supports the expanded approval of OCA.

GLI supports the FDA’s decision to allow Intercept Pharmaceuticals to continue pursuing additional studies while maintaining the availability of OCA during this process. While this ongoing research may take several years, it is essential to ensure that patients receive treatments validated by rigorous data with guaranteed benefit and well-understood risks. GLI remains committed to collaborating to ensure that patient voices are integral to these efforts and to support the development of the strongest possible data for OCA.

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.