Gilead announces positive CHMP opinion for seladelpar

Gilead (GILD) Sciences announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending seladelpar for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. The final European Commission decision is anticipated in the first quarter of 2025. This follows the accelerated approval by the U.S. FDA in August 2024.