Gilead Sciences has announced that the US Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) to treat primary biliary cholangitis (PBC) in adults who are unable to tolerate or do not respond adequately to ursodeoxycholic acid (UDCA). Livdelzi, an oral peroxisome proliferator-activated receptor (PPAR) delta agonist, is the first of its kind approved for PBC in combination with UDCA or as a standalone therapy. The approval is based on the Phase 3 RESPONSE study, which showed that Livdelzi significantly improved biochemical markers of liver disease, including normalizing alkaline phosphatase (ALP) levels in 25% of participants at 12 months.
The RESPONSE study demonstrated that Livdelzi, either alone or with UDCA, effectively reduced pruritus, a debilitating symptom of PBC, and showed substantial improvements in ALP levels compared to placebo. Despite the promising results, continued approval of Livdelzi may depend on further confirmatory trials verifying long-term clinical benefits. Gilead Sciences remains dedicated to advancing treatments for liver diseases and improving patient outcomes through innovative therapies.
