Intercept announced voluntary withdrawal of Ocaliva (obeticholic acid) from the US market
On September 11th, 2025, Intercept announced voluntary withdrawal of Ocaliva (obeticholic acid) from the US market for treatment of PBC following a request from the FDA.
The withdrawal follows a CRL from the FDA in November 2024 denying full approval and a safety update in December 2024 reporting additional cases of severe liver injury in PBC patients without cirrhosis.
In addition, the FDA has placed a hold on all Intercept-sponsored clinical trials conducted under a US IND involving obeticholic acid, effectively halting development of the combination therapy with Bezafibrate in the US, including:
- Phase 2 US PBC trial (N=60; PCD: Oct 2025) assessing Ocaliva + bezafibrate (OCA + BZF)
- Phase 3 long-term extension PBC safety study (N=133; PCD: Jan 2029) for OCA + BZF.
It is unclear if Intercept’s ex-US Phase 2 trial (N=72; PCD: Oct 2025) evaluating OCA + BZF will be impacted.
Ocaliva was first granted accelerated approval by the FDA in May 2016 based on ALP reduction, with full approval contingent on establishing clinical benefit. Intercept subsequently failed to achieve full approval for 2L PBC after its confirmatory outcomes trial POISE did not demonstrate benefit in liver fibrosis.
In its press release, Intercept mentions that it “continues to believe in clinical and real-world evidence that support Ocaliva’s use”, however, acknowledges that while its view on Ocaliva “differs” from the FDA, the company “respects” the agency’s request.
Following this announcement, a pop-up message now appears on both the Ocaliva patient and HCP websites announcing withdrawal from the US market and guiding HCPs to reach out to Intercept’s Medical Information team with any inquiries.
While Ocaliva is still approved for 2L PBC in the UK and Canada, it is possible that both countries might also reassess Ocaliva’s position in these respective markets. Conditional marketing authorization was revoked in the EU by the European Commission (EC) in Sep 2024. Advanz, is currently fighting the decision, and awaits legal proceedings with the EU General Court.