Gilead Sciences Receives Conditional EU Approval for Breakthrough Small Molecule Drug Seladelpar to Treat Life-Threatening Liver Disease PBC

SmartCom APP learned that Gilead Sciences, Inc. (GILD.US) recently announced that the European Commission (EC) has granted conditional approval for the marketing of seladelpar in combination with ursodeoxycholic acid (UDCA) to treat patients with primary biliary cholangitis (PBC) who have an inadequate response to UDCA monotherapy, or as a monotherapy for PBC patients intolerant to UDCA treatment.

Seladelpar has received accelerated approval from the U.S. FDA in August 2024 (brand name Livdelzi) for the treatment of PBC. Seladelpar was granted Breakthrough Therapy Designation and Orphan Drug Designation for PBC by the FDA, as well as PRIME designation by the European Medicines Agency. As part of the FDA's accelerated approval, Gilead Sciences is committed to conducting a confirmatory long-term outcomes study named AFFIRM, which has already been initiated in patients with compensated cirrhosis.