Gilead Sciences, Inc. (GILD.US) has received approval from the European Union for its groundbreaking small molecule drug used to treat deadly liver diseases.

Gilead Sciences, Inc. (GILD.US) recently announced that the European Commission (EC) has conditionally approved the marketing of seladelpar, in combination with ursodeoxycholic acid (UDCA), for the treatment of primary biliary cholangitis (PBC) patients who have inadequate response to UDCA as a monotherapy. It can also be used as a monotherapy for PBC patients who are intolerant to UDCA. Seladelpar was granted accelerated approval by the US FDA in August 2024 (under the brand name Livdelzi) for the treatment of PBC. Seladelpar has also received breakthrough therapy designation from the FDA, orphan drug designation for PBC patients, and PRIME designation from the European Medicines Agency. As part of the FDA accelerated approval, Gilead has committed to conducting a confirmatory long-term outcomes study called AFFIRM, which has already been initiated in compensated cirrhotic patients.