Gilead Sciences, Inc. (GILD) disclosed on Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a favorable opinion recommending the use of seladelpar for treating primary biliary cholangitis (PBC). This recommendation applies to its use in conjunction with ursodeoxycholic acid (UDCA) for adults who do not adequately respond to UDCA alone, or as a standalone therapy for those unable to tolerate UDCA.
The conclusive decision from the European Commission is expected in the first quarter of 2025, following the U.S. Food and Drug Administration's (FDA) expedited approval in August 2024.
PBC is a chronic, autoimmune condition affecting the bile ducts, impacting approximately 15 out of every 100,000 people in Europe, predominantly women. If untreated, this ailment can lead to liver damage and potential liver failure.
The positive recommendation is chiefly backed by findings from the pivotal Phase 3 RESPONSE study, which was placebo-controlled. In this study, 62% of participants receiving seladelpar reached the primary endpoint of a composite biochemical response at 12 months, as opposed to 20% among those given a placebo.
Furthermore, the treatment resulted in the normalization of ALP values in 25% of participants by the 12-month mark, a change not observed in any participant from the placebo group.
The RESPONSE study is a Phase 3, double-blind, placebo-controlled clinical trial aimed at evaluating the effectiveness and safety of seladelpar in adults with PBC who have either shown inadequate response to or cannot tolerate first-line treatment with UDCA.
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