2024 CMYK White Gli Logo

GLI Celebrates with PBC Patient Community upon U.S. FDA’s Approval of Second-Line Treatment

(Washington, D.C. June 10, 2024) – Global Liver Institute (GLI) celebrates the decision of the U.S. Food and Drug Administration (FDA) to provide accelerated approval to elafibranor (Iqirvo®) to Ipsen (licensed from GENFIT) as a second-line option for patients diagnosed with the rare liver disease primary biliary cholangitis (PBC). 

PBC is a progressive disease that degrades bile ducts in the liver, which leads to bile buildup and liver damage that can require a liver transplant. The disease most commonly affects women between the ages of 40-60. It is estimated that about 1 in 1,000 women over the age of 40 are affected by PBC.

About 40 percent of PBC patients do not respond to first-line therapy, so elafibranor now offers a new option for a sizable portion of the patient population. Patients may benefit from effects noted during the studies like improved biochemical responses, normalized alkaline phosphatase (ALP) levels, and even reductions in pruritus. 

“The journey of drug development is challenging and complex, but it is through continued innovation that breakthroughs like these are achieved,” shared Kristin Hatcher, Program Director of Pediatric and Rare Liver Diseases at GLI. “For patients facing a progressive rare liver disease like PBC, the right treatment to slow down progression is essential – and this breakthrough offers hope for those who do not respond to what is on the market today. It’s about avoiding the uncertainties of a liver transplant and placing trust in therapies that truly make a difference for patients.”

GLI celebrates with the PBC community the increased hope and quality of life that this new option for treatment offers – as well as its potential to address other rare liver conditions like primary sclerosing cholangitis. We will continue to advocate for robust research and equitable access to treatments for all people with rare liver diseases.

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. Learn more about the Liver Health is Public Health program here.