Long Regulatory Saga for Intercept Pharma Liver Drug Ends a Decade After Speedy FDA Approval

MedCity News September 12, 2025
Frank Vinluan

Intercept Pharmaceuticals is voluntarily withdrawing from the market Ocaliva, a drug for the rare liver disease primary biliary cholangitis. While Ocaliva became an important new treatment option when it won accelerated FDA approval in 2016, PBC patients now have new FDA-approved medicines from Ipsen and Gilead Sciences that don’t pose the same safety risks.

While the path for any drug to go from lab research to commercialization takes years, Intercept Pharmaceuticals now stands as another example that a product’s market exit can also be long and winding. Nearly a decade after Intercept’s drug for a rare liver disease received accelerated FDA approval, the company is withdrawing the product.

Intercept said Thursday its withdrawal of the drug, Ocaliva, is voluntary. But...

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