Updated July 29, 2020 // Editor's note: This commentary has been updated to include that Intercept Pharmaceuticals received a Complete Response Letter on June 29, 2020, regarding its New Drug Application for obeticholic acid for the treatment of fibrosis due to nonalcoholic steatohepatitis.
In the middle of the last decade, nonalcoholic steatohepatitis (NASH) overtook chronic hepatitis C virus infection as the leading indication for liver transplantation wait-listing in US adults born between 1945 and 1965. If predictive modeling proves accurate, NASH is unlikely to surrender this dubious distinction anytime soon. Owing to an increased rate of diabetes and obesity in an aging population, the prevalence of NASH is forecasted to surge 63% between 2015 and 2030.
As the clinical burden wrought by NASH has become increasingly clear, so too has the failure to develop effective treatments against it. There are currently no US Food and Drug Administration (FDA)-approved pharmaceutical therapies for this pervasive and deadly disease, despite there being over 200 active clinical trials of nonalcoholic fatty liver disease treatments. There was cautious optimism, however, that 2020 would mark the year that this begins to change.
Obeticholic acid (OCA), which is already approved for the management of primary biliary cholangitis
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COMMENTARY
Obeticholic Acid for NASH: Revolution or Just a Ripple?
Jason B. Kramer, MD, MS; Nancy S. Reau, MD
DisclosuresJuly 10, 2020
Updated July 29, 2020 // Editor's note: This commentary has been updated to include that Intercept Pharmaceuticals received a Complete Response Letter on June 29, 2020, regarding its New Drug Application for obeticholic acid for the treatment of fibrosis due to nonalcoholic steatohepatitis.
In the middle of the last decade, nonalcoholic steatohepatitis (NASH) overtook chronic hepatitis C virus infection as the leading indication for liver transplantation wait-listing in US adults born between 1945 and 1965. If predictive modeling proves accurate, NASH is unlikely to surrender this dubious distinction anytime soon. Owing to an increased rate of diabetes and obesity in an aging population, the prevalence of NASH is forecasted to surge 63% between 2015 and 2030.
As the clinical burden wrought by NASH has become increasingly clear, so too has the failure to develop effective treatments against it. There are currently no US Food and Drug Administration (FDA)-approved pharmaceutical therapies for this pervasive and deadly disease, despite there being over 200 active clinical trials of nonalcoholic fatty liver disease treatments. There was cautious optimism, however, that 2020 would mark the year that this begins to change.
Obeticholic acid (OCA), which is already approved for the management of primary biliary cholangitis
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Cite this: Obeticholic Acid for NASH: Revolution or Just a Ripple? - Medscape - Jul 10, 2020.
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Authors and Disclosures
Authors and Disclosures
Authors
Jason B. Kramer, MD, MS
Fellow, Gastroenterology and Hepatology, Rush University Medical Center, Chicago, Illinois
Disclosure: Jason B. Kramer, MD, MS, has disclosed no relevant financial relationships.
Nancy S. Reau, MD
Professor, Department of Internal Medicine, Rush University; Section Chief, Hepatology; Associate Director of Organ Transplant, Rush University Medical Center, Chicago, Illinois
Disclosure: Nancy S. Reau, MD, has disclosed the following financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie Inc.; Gilead Sciences, Inc.; Bristol-Myers Squibb Company; Merck & Co., Inc.; Intercept Pharmaceuticals, Inc.
Received income in an amount equal to or greater than $250 from: American Board of Internal Medicine