Co-founder and CEO Wayne Eskridge addresses the FDA Gastrointestinal Drugs Advisory Committee (GIDAC), representing millions of NASH patients awaiting a much-needed treatment option
May 19, 2023; Boise, IDAHO — Today marks a significant moment in the fight against non-alcoholic steatohepatitis (NASH) as the U.S. Food and Drug Administration’s Gastrointestinal Drugs Advisory Committee (GIDAC) convenes its public meeting to assess the New Drug Application for obeticholic acid (OCA), a potential new treatment option for NASH. As this discussion could significantly influence future FDA decisions, millions of NASH patients across the U.S. are keenly observing its progress. The Fatty Liver Foundation (FLF) remains resolute in advocating for their needs. The urgency is clear – there is a dire unmet need in NASH treatment. Now more than ever, FLF is unwavering in its commitment to vigorously advocate for these patients.
FLF is an independent, non-profit, patient-driven organization dedicated to championing the cause of those with fatty liver, nonalcoholic fatty liver disease (NAFLD), and NASH. Our mission is multi-prong, emphasizing the importance of raising disease awareness, promoting early and accurate diagnosis through non-invasive screening techniques, empowering patients with education, and establishing responsive support systems.
Wayne Eskridge, Co-Founder and CEO of FLF and a NASH patient himself, will have a brief window for public comment during the GIDAC meeting. “I will use these precious 4 minutes to voice the concerns and hopes of all those affected by NASH. The decisions made in this meeting could greatly impact your life,” Eskridge emphasized.
While OCA offers potential as a treatment for NASH, it faces contentious debate. The FDA’s briefing document with its internal staff analysis appears, from the FLF’s interpretation, to indicate a resistance towards OCA’s approval. “We believe this could be a significant misstep,” said Henry E. Chang, Executive Director of FLF, “If the GIDAC’s decision reflects this analysis, it may result in a considerable setback for NASH patients and could jeopardize the flow of investments and advancements in the research and development of new NASH therapeutics,” stated Chang.
The FDA’s concerns center around OCA’s potential to raise patients’ LDL levels and cause itching. However, as Eskridge points out, these issues are manageable. “The elevated LDL can be controlled with statins, and if that is not effective for some patients, they can discontinue OCA. Similarly, there are treatments available for itching.”
Eskridge asserts that given OCA is the first drug that has met the FDA’s surrogate endpoint of improvement in fibrosis by one or more stage with no worsening of NASH, it should be approved to address this dire unmet need. Speaking from a patient’s perspective, he states, “I would be more than willing to take a statin alongside OCA to manage my LDL levels, and as for the itching, I would rather experience that discomfort than the alternative.”
Eskridge emphasizes the potential significance of this emerging therapy. “While OCA may not be the ultimate solution, it presents a crucial and timely advance in reducing fibrosis and halting the disease progression for a substantial subset of NASH patients,” said Eskridge.
As the FDA GIDAC meeting unfolds, FLF awaits its potential impact on the NASH drug development landscape. “The outcomes of this meeting could serve as a watershed moment in NASH treatment. “We value the GIDAC’s careful evaluation and consideration, and we trust they will take into account the significant and direct impacts their recommendations will have on the lives of NASH patients,” said Chang.
About the Fatty Liver Foundation
The Fatty Liver Foundation is a non-profit patient organization dedicated to improving the identification, diagnosis, treatment and support of people living with fatty liver, NAFLD or NASH through awareness, screening, education, and patient outreach. FLF’s goal is to improve the lives of both asymptomatic and diagnosed patients by raising awareness, advancing wellness screening, educating patients, and championing the development of responsive support systems for individuals of the growing epidemic of fatty liver disease. Connect with us on www.fattyliverfoundation.org, Facebook (Fatty Liver Foundation JUST LIVER NEWS), Twitter (@LiverSaver), and YouTube (Fatty Liver Foundation).
Fatty Liver Foundation
Henry E. Chang | Mobile +1 917 400 8900 | [email protected]
# # #