Gilead's Seladelpar Gains Conditional EU Approval for PBC Treatment Following Iqirvo's Success

Gilead Sciences has announced that the European Commission (EC) has granted conditional approval for seladelpar, used in conjunction with ursodeoxycholic acid (UDCA), for the treatment of patients with primary biliary cholangitis (PBC) who do not respond adequately to UDCA alone. Seladelpar can also be administered as a standalone treatment for patients intolerant to UDCA.

Seladelpar is a potent, oral selective peroxisome proliferator-activated receptor delta (PPARδ) agonist. Research indicates that PPARδ plays a crucial role in regulating key metabolic and liver disease pathways. In August 2024, seladelpar received accelerated approval from the FDA for PBC treatment. It has been designated as a breakthrough therapy and granted orphan drug designation by the FDA, and has also received PRIME status from the European Medicines Agency.

The EU approval is primarily based on the results from the pivotal Phase 3 RESPONSE trial. In this study, 62% of participants treated with seladelpar achieved the primary endpoint of a composite biochemical response at 12 months, compared to only 20% in the placebo group. Additionally, 25% of those receiving seladelpar normalized their alkaline phosphatase (ALP) levels by month 12, a change not seen in the placebo group. Significant reductions in itching scores at six months compared to baseline were also noted in patients receiving seladelpar.

As part of the FDA's accelerated approval process, Gilead has committed to conducting a confirmatory long-term outcomes study named AFFIRM, which has already begun in patients with compensated cirrhosis.