GILD Obtains Positive CHMP Opinion for Liver Disease Drug

Gilead Sciences, Inc. (GILD) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended approval of seladelpar.The CHMP adopted a positive opinion recommending 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.A final decision from the European Commission is expected in ...