07:39 AM EST, 12/13/2024 (MT Newswires) -- Gilead Sciences' ( GILD ) investigational drug seladelpar received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for the treatment of primary biliary cholangitis, an autoimmune liver disease, the European regulator said Friday.

In a statement, Gilead said the CHMP's recommendation was for seladelpar as treatment for primary biliary cholangitis in combination with ursodeoxycholic acid, or UDCA, for adults with an inadequate response to UDCA alone, or as monotherapy for those unable to tolerate UDCA.

A final decision by the European Commission is expected in Q1 2025, Gilead said.

The CHMP's recommendation was based on results from a pivotal phase 3 trial, where 62% of participants treated with seladelpar achieved the primary goal of a composite biochemical response at 12 months compared with the 20% on placebo, Gilead said. Additionally, 25% of seladelpar-treated patients achieved ALP normalization at 12 months versus none on placebo, the company said.