Gilead’s Seladelpar Receives Conditional EU Approval for Primary Biliary Cholangitis Treatment

The European Commission granted conditional marketing authorization for Gilead's seladelpar to treat primary biliary cholangitis (PBC) in adults1.

Seladelpar is approved for use in combination with ursodeoxycholic acid (UDCA) in adults with inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA1.

The approval is based on the Phase 3 RESPONSE trial results, which demonstrated significant improvements in biochemical response and pruritus symptoms compared to placebo2.

In the RESPONSE trial, 61.7% of patients receiving seladelpar achieved a biochemical response at 12 months, compared to 20% in the placebo group2.

Seladelpar is the first and only treatment to show statistically significant improvements across biochemical response, alkaline phosphatase normalization, and pruritus versus placebo1.

The drug has already received accelerated approval in the U.S. (August 2024) and approval in the UK (January 2025)1.

Continued authorization in the EU is contingent on verification of clinical benefit in confirmatory trials1.

PBC affects approximately 163,000 people in Europe, primarily women7.

Seladelpar's safety profile appears manageable, with adverse events reported in 86.7% of patients in the seladelpar group compared to 84.6% in the placebo group2.

The approval marks an important expansion of treatment options for PBC patients in Europe who have an inadequate response to or cannot tolerate first-line UDCA therapy17.

Sources:

1. https://www.gilead.com/news/news-details/2025/gileads-seladelpar-granted-conditional-european-marketing-authorization-for-the-treatment-of-primary-biliary-cholangitis

2. https://pubmed.ncbi.nlm.nih.gov/38381664/

7. https://www.stocktitan.net/news/GILD/gilead-s-seladelpar-granted-conditional-european-marketing-bmdb4vszxsq9.html