Intercept announces voluntary withdrawal of Ocaliva® for primary biliary cholangitis (PBC)

  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.

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. 

https://www.globenewswire.com/news-release/2025/09/11/3148535/23024/en/Intercept-Announces-Voluntary-Withdrawal-of-OCALIVA-for-Primary-Biliary-Cholangitis-PBC-from-the-US-Market-US-Clinical-Trials-Involving-Obeticholic-Acid-Placed-on-Clinical-Hold.html