05:44 PM EST, 02/20/2025 (MT Newswires) -- Gilead Sciences ( GILD ) said the European Commission granted conditional marketing authorization for seladelpar in combination with ursodeoxycholic acid to treat primary biliary cholangitis, a rare liver disease.

The treatment targets adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA, the company said late Thursday.

Seladelpar is now approved for the European Economic Area.

The company said the European regulator's decision is primarily based on results from a placebo-controlled phase 3 study in which 62% of participants taking seladelpar achieved the primary endpoint of composite biochemical response at Month 12, versus 20% taking placebo.