Gilead Sciences Says Seladelpar Gets Positive CHMP Opinion For Primary Biliary Cholangitis

(RTTNews) - Gilead Sciences, Inc. (GILD) announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) 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.

The final European Commission decision is anticipated in the first quarter of 2025. This follows the accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2024.

PBC is a rare, chronic, autoimmune disease of the bile ducts that affects approximately 15 per 100,000 people in Europe, primarily women, and can cause liver damage and possible liver failure if untreated.

The positive opinion was supported primarily by data from the pivotal placebo-controlled Phase 3 RESPONSE study. In the study, 62% of participants taking seladelpar achieved the primary endpoint of composite biochemical response at month 12 compared with 20% of participants taking placebo.

Treatment with seladelpar led to normalization of ALP values in 25% of trial participants at month 12. This change was not seen in any trial participants receiving placebo.

RESPONSE is a Phase 3, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of seladelpar in adults with PBC who have shown inadequate response or intolerance to first-line treatment with UDCA.