In an unusual turn of events, the EU's top court has temporarily suspended the European Commission's decision to revoke the marketing authorisation for a drug used to treat the rare autoimmune liver disease.
ADVERTISEMENTObeticholic acid, marketed as Ocaliva, is prescribed to adult patients with primary biliary cholangitis (PBC), a condition that progressively destroys bile ducts in the liver, potentially leading to liver failure and increasing the risk of liver cancer.
The European Medicines Agency (EMA) recently recommended withdrawing the drug's marketing authorisation following a review by its Committee for Medicinal Products for Human Use (CHMP).
The review concluded that Ocaliva showed no significant benefit over a placebo in preventing disease progression or death in early-stage PBC patients. Following this recommendation, the Commission formally moved to ban the drug earlier this week.
However, Advanz Pharma, the manufacturer of Ocaliva, swiftly announced it had secured a temporary suspension of the ban from the EU's Court of Justice in Luxembourg.
A court spokesperson confirmed the decision to Euronews, though the official order has not yet been made public.
The suspension is an interim measure pending the outcome of a lawsuit filed by Advanz Pharma challenging the Commission’s decision. In the meantime, the ruling ensures that Ocaliva remains available to patients in the EU until further notice.
"The Commission acknowledges the interim order but cannot provide further comments as the case is still pending before the court," said a spokesperson for the EU executive.
The potential removal of Ocaliva from the market had already sparked protests, with a group of PBC patients staging a demonstration outside the EU Council in Brussels in late July.
The drug is typically used when initial treatments fail, stop working, or cause intolerable side effects.
Some patient advocacy groups argue that there is no alternative second-line treatment licensed in Europe for PBC, underscoring the importance of Ocaliva for patients whose first-line treatments are ineffective.
Ocaliva was initially granted conditional marketing authorisation in 2016, contingent on further studies to confirm its clinical benefits.
