MORRISTOWN, N.J., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a wholly owned biopharmaceutical subsidiary of Alfasigma S.p.A., today announced its decision to voluntarily withdraw OCALIVA® (obeticholic acid) from the US market for the treatment of primary biliary cholangitis (PBC), a rare, progressive liver disease. This decision follows a request from the US Food and Drug Administration (FDA). In addition, FDA has placed a clinical hold on all Intercept clinical trials conducted under a US IND involving obeticholic acid.
“We continue to believe the totality of clinical and real-world evidence supports OCALIVA’s use for appropriate patients, and we are proud of the contribution OCALIVA has made in advancing care for people living with PBC. While our view of OCALIVA’s benefit-risk profile differs from FDA’s, we respect its request and have made this difficult decision to provide clear guidance for patients and prescribers,” said Vivek Devaraj, US President at Intercept. “We remain committed to innovation in hepatology and to serving the needs of patients and physicians.”
OCALIVA received FDA accelerated approval in 2016 for the treatment of PBC in adults with an inadequate response to or intolerance of ursodeoxycholic acid (UDCA). Since then, OCALIVA has played a meaningful role in the treatment landscape for patients living with this rare disease.
Patients currently prescribed OCALIVA for PBC treatment should consult their healthcare professionals before making any changes. Intercept will provide additional information to support healthcare professionals and patients as it works with FDA on the transition process.
Healthcare professionals who have questions about OCALIVA can contact Intercept Medical Information at medinfo@interceptpharma.com or call 1-844-782-4278. Patients should speak with their healthcare professionals and also may contact Intercept’s Patient Support Services (Interconnect) at 1-844-622-4278.
About Primary Biliary Cholangitis
Primary biliary cholangitis (PBC) is a rare, progressive, and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent (approximately 1 in 10,000) in women over the age of 40. PBC causes bile acid to build up in the liver, resulting in inflammation and scarring (fibrosis), which, if left untreated, can lead to cirrhosis, a liver transplant, or death.
About Intercept
Intercept, part of the Alfasigma Group since 2023, focuses on the development and commercialization of novel therapeutics to treat serious liver and GI diseases, including primary biliary cholangitis (PBC) and severe alcohol-associated hepatitis (sAH). Intercept owns the commercial rights to OCALIVA in the U.S. market. For more information, please visit www.interceptpharma.com or connect with the Company on LinkedIn, and X (formerly Twitter).
About Alfasigma
Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in many countries, including Italy, the United States (US), Spain, Germany, Mexico, and China; production sites in Italy, Spain, and the US; and R&D labs in Italy (Pomezia and Bergamo).
Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products contributing to its mission to provide better health and a better quality of life for patients, caregivers, and healthcare providers. It focuses on three main therapeutic areas: Gastroenterology/Hepatology, Vascular, and Rheumatology. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical foods and nutraceuticals. For more information, please visit www.alfasigma.com or connect with the Company on LinkedIn.
About OCALIVA® (obeticholic acid)
OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC)
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without cirrhosis or
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with compensated cirrhosis who do not have evidence of portal hypertension,
either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.