Gilead Sciences (NASDAQ: GILD) has secured conditional marketing authorization from the European Commission (EC) for seladelpar, a breakthrough treatment for primary biliary cholangitis (PBC), a chronic liver disease.
Seladelpar Gains EU Green Light for PBC Treatment
The approval allows seladelpar to be used in combination with ursodeoxycholic acid (UDCA) for patients who do not respond well to UDCA alone or as a standalone treatment for those who cannot tolerate UDCA.
This regulatory milestone follows a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2024.
Clinical Trial Success: Seladelpar Outperforms Placebo
The European Commission’s decision was largely based on results from a late-stage clinical trial, where seladelpar demonstrated significant efficacy:
- 62% of patients achieved a composite biochemical response at Month 12.
- This was compared to only 20% in the placebo group.
With EU approval secured, seladelpar is now set to play a crucial role in advancing treatment options for PBC patients who have limited therapeutic choices.
