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