OCALIVA, a once promising drug for the treatment of primary biliary cholangitis, is now seeing its future in Europe seriously compromised. The European Medicines Agency has recommended the revocation of its marketing authorisation following disappointing clinical trial results. What led to this decision and what are the consequences for patients? Decryption.
By Thomas Kassab, published on August 13, 2024
Specific context of use The European Medicines Agency (EMA) has recently recommended the revocation of the conditional marketing authorisation (MA) for OCALIVA, a medicine for the treatment of primary biliary cholangitis (PBC). This decision follows study results that failed to demonstrate convincing clinical efficacy. OCALIVA: mechanism of action and indications OCALIVA, containing obeticholic acid as the active substance, was initially granted conditional MA in December 2016. This medicine is used as an adjunct to ursodeoxycholic acid (UDCA) in adults with an inadequate response to the latter, or as monotherapy in those who cannot tolerate it. PBC is a rare, autoimmune liver disease, leading to damage to the small intrahepatic bile ducts, resulting in cholestasis, fibrosis, and…
