Gilead Gets Key European Backing for Liver-Disease Treatment

GILD

By Colin Kellaher

Gilead Sciences said a key European regulatory committee recommended expanded approval of its seladelpar treatment for patients with primary biliary cholangitis, a chronic and progressive liver disease.

The biopharmaceutical company Friday said the recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use covers seladelpar in combination with ursodeoxycholic acid, or UDCA, in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.

The European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected in the first quarter.

The U.S. Food and Drug Administration in August granted accelerated approval to seladelpar, which the Foster City, Calif., company markets as Livdelzi. The drug was the key asset in Gilead's $4.3 billion acquisition of CymaBay Therapeutics earlier this year.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

12-13-24 0719ET