Seladelpar wins conditional EC approval for rare liver disease

21 February 2025

Gilead Sciences’ (Nasdaq: GILD) seladelpar has won conditional marketing authorization to treat primary biliary cholangitis (PBC) alongside 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.

María-Carlota Londoño, hepatologist at Hospital Clinic Barcelona, said: “Today’s decision reinforces the clinical benefit and value of seladelpar and offers people living with PBC in Europe an important new treatment option.

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