Intercept Withdraws Ocaliva from US Market After FDA Safety Concerns
Intercept Pharmaceuticals has withdrawn its liver disease drug Ocaliva (obeticholic acid) from the US market at the request of the FDA after years of regulatory setbacks and mounting safety concerns.15679
The FDA identified cases of serious liver injury in patients with primary biliary cholangitis (PBC) treated with Ocaliva, especially in those without liver cirrhosis, raising significant safety concerns that contributed to the decision.2310
Ocaliva was initially granted conditional approval by the FDA in 2016 as a second-line therapy for PBC patients who did not respond to standard treatment, but failed to gain full approval for this indication following an adverse FDA advisory committee vote (10-1 against full approval).8
The drug also failed in attempts to expand approval to other liver diseases such as metabolic dysfunction-associated steatohepatitis (MASH), resulting in program cancellations and layoffs at Intercept.2
Following these regulatory setbacks and the drug’s market withdrawal, US clinical trials involving obeticholic acid have been placed on clinical hold.97
Although Intercept’s internal safety review found no new safety signals within the currently approved population, the FDA continues to evaluate the risks and recommends clinicians monitor patients closely if the drug is used elsewhere.4
Intercept Pharmaceuticals was recently acquired by Italian company Alfasigma amid ongoing challenges.2
Sources:
1. https://firstwordpharma.com/story/6061481
2. https://www.biospace.com/drug-development/intercepts-troubled-drug-ocaliva-linked-to-serious-liver-injury-fda
3. https://www.pharmexec.com/view/intercept-pharmaceuticals-withdraws-ocaliva-shelves-following-regulator-request
4. https://www.interceptpharma.com/about-us/ocaliva-facts/
5. https://lifescivoice.com/fda-requests-withdrawal-of-intercepts-ocaliva-from-u-s-market/
6. https://www.hcplive.com/view/intercept-voluntarily-withdrawals-obeticholic-acid-ocaliva-for-pbc-from-us-market
7. https://www.fiercepharma.com/pharma/intercept-pulls-liver-disease-drug-ocaliva-us-after-regulatory-struggles-fda-orders-clinical
8. https://liverdiseasenews.com/news/full-approval-pbc-therapy-ocaliva-rejected-fda-committee-10-1-vote/
9. https://www.globenewswire.com/news-release/2025/09/11/3148535/0/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