Gilead’s Seladelpar granted conditional European marketing authorization

Gilead (GILD) Sciences announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Seladelpar (an orphan designated product) is now approved and will provide an important treatment option for people living with the rare liver disease in the European Economic Area (EEA). “Today’s decision reinforces the clinical benefit and value of seladelpar and offers people living with PBC in Europe an important new treatment option,” said Maria-Carlota Londono, MD, PhD, Hepatologist at Hospital Clinic Barcelona. “There are people in Europe who do not have an adequate response to first-line therapy and seladelpar helps address the unmet need for effective and symptom-directed treatment.”