FDA Reviewers Skeptical of Ocaliva for Rare Bile Duct Disease | MedPage Today
FDA advisors will assess obeticholic acid's (Ocaliva) clinical benefit in PBC, despite null post-approval evidence. Intercept Pharmaceuticals seeks an indication for reducing hepatic decompensation, liver transplant, and death in PBC patients with compensated cirrhosis, using the drug with or without UDCA. FDA reviewers doubt the drug's efficacy for PBC patients intolerant or unresponsive to UDCA, citing failed postmarketing trials. The advisory committee will vote on whether the drug's benefits outweigh risks in non-contraindicated PBC patients.
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FDA advisors voted 10-1 against full approval of obeticholic acid (Ocaliva) for primary biliary cholangitis (PBC), citing insufficient data and safety concerns. The main trial, COBALT, showed trends of excess liver transplants and death. The drug had previously received accelerated approval in 2016, but now risks withdrawal from the market.
FDA advisors will assess obeticholic acid's (Ocaliva) clinical benefit in PBC, despite null post-approval evidence. Intercept Pharmaceuticals seeks an indication for reducing hepatic decompensation, liver transplant, and death in PBC patients with compensated cirrhosis, using the drug with or without UDCA. FDA reviewers doubt the drug's efficacy for PBC patients intolerant or unresponsive to UDCA, citing failed postmarketing trials. The advisory committee will vote on whether the drug's benefits outweigh risks in non-contraindicated PBC patients.