Intercept Withdraws Liver Disease Drug from U.S. Market
The company has decided to voluntarily withdraw obeticholic acid from the U.S. market after the FDA issued a request for the withdrawal and put a clinical hold on trials involving the drug.
Liver disease drug, obeticholic acid (OCALIVA), has been voluntarily withdrawn from the U.S. market by Intercept Pharmaceuticals, following a request from the FDA. The company announced its decision to pull the drug from the market in a Sept. 11, 2025 press release (1).
“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, U.S. President at Intercept, in the press release (1). “We remain committed to innovation in hepatology and to serving the needs of patients and physicians.”
Obeticholic acid is a selective farnesoid X receptor (FXR) agonist that works by decreasing circulating bile acid. Intercept received accelerated approval for the drug in 2016 as a treatment of adults with primary biliary cholangitis (PBC) — a rare, progressive liver disease — who had an inadequate response to or intolerance of ursodeoxycholic acid (UDCA).
Back in November 2024, the company was denied full approval of the drug by the FDA. In a Complete Response Letter (CRL), the FDA specified that it was unable to approve the supplemental New Drug Application (sNDA) for obeticholic acid in its current form — a decision that was consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting two months earlier (2). Furthermore, the regulatory authority specified in the CRL that it would be continuing to consider safety data for the drug.
In Europe, where the drug has been marketed by Advanz Pharma since 2022, the regulatory authority — the European Medicines Agency — recommended that the conditional marketing authorization be revoked as the benefits were no longer considered to outweigh the risks. The agency’s human medicines committee (CHMP) had reviewed all available data and found that the clinical benefits of the drug had not been confirmed and that in study 747-302, the drug had not been shown to be more effective than placebo (3).
Despite gaining a temporary suspension to the decision in Europe, Advamz Pharma confirmed that the authorization revocation decision was in force with immediate effect from November 2024 (4).
References
Intercept Pharmaceuticals. Intercept Announces Voluntary Withdrawal of OCALIVA for Primary Biliary Cholangitis (PBC) from the U.S. Market; U.S. Clinical Trials Involving Obeticholic Acid Placed on Clinical Hold. Press Release, Sept. 11, 2025.
Intercept Pharmaceuticals. Intercept Receives Complete Response Letter from FDA Addressing OCALIVA supplemental New Drug Application (sNDA). Press Release, Nov. 12, 2024.
EMA. EMA Recommends Revoking Conditional Marketing Authorization for Ocaliva. Press Release, June 28, 2024.
Advanz Pharma.ADVANZ PHARMA’s Response to the Reversal of the Suspension of the European Commission Decision on the OCALIVA Conditional Marketing Authorization in Europe. Press Release, Nov. 27, 2024.