Biopharmaceutical company Gilead Sciences Inc (Nasdaq: GILD) announced on Friday that it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for seladelpar as a treatment for primary biliary cholangitis (PBC). The recommendation applies to patients with inadequate response to ursodeoxycholic acid (UDCA) or those unable to tolerate it. A final decision from the European Commission is expected in the first quarter of 2025.

The pivotal Phase 3 RESPONSE trial demonstrated seladelpar's efficacy, with 62% of participants achieving a composite biochemical response at 12 months compared to 20% on placebo. Seladelpar normalised alkaline phosphatase (ALP) levels, a key marker of disease progression, in 25% of patients versus none in the placebo group. Significant reductions in pruritus, a debilitating symptom of PBC, were also observed.

PBC, a rare autoimmune liver disease primarily affecting women, is characterised by chronic inflammation and impaired bile flow, leading to liver damage. Current treatments often fail to address symptoms like pruritus and fatigue, underscoring the unmet need for effective second-line therapies.

Seladelpar, an oral PPAR-delta agonist, is designed to modulate liver disease pathways, showing anticholestatic, anti-inflammatory, antipruritic and antifibrotic properties. It received accelerated approval from the U.S. Food and Drug Administration in August 2024, with ongoing confirmatory trials. Regulatory reviews are underway in other markets, including the UK.

Gilead Sciences, known for its leadership in liver disease treatments, continues to advance solutions for conditions like hepatitis and PBC. Seladelpar's potential approval in Europe could mark a significant milestone for patients and strengthen the company's portfolio in addressing unmet medical needs.