FDA Grants Accelerated Approval for Livdelzi (seladelpar) for the Treatment of Primary Biliary Cholangitis
FDA grants accelerated approval for Livdelzi (seladelpar) for treating primary biliary cholangitis (PBC) in adults, either with ursodeoxycholic acid (UDCA) for inadequate response or as monotherapy for those unable to tolerate UDCA. The approval is based on a Phase 3 study showing 62% of Livdelzi-treated participants achieved a composite biochemical response at month 12, compared to 20% on placebo. Livdelzi led to ALP normalization in 25% of participants, a significant reduction in pruritus, and no treatment-related serious adverse events.
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Livdelzi® (seladelpar), a PPARδ agonist, treats primary biliary cholangitis (PBC) in adults, either with UDCA or as a monotherapy for UDCA-intolerant patients. Gilead Sciences acquired CymaBay Therapeutics, expanding its liver portfolio with seladelpar in 2024. The FDA granted accelerated approval in August 2024, based on the Phase III RESPONSE study, showing 62% of Livdelzi recipients achieved the primary endpoint of composite biochemical response, compared to 20% on placebo. Livdelzi also normalized ALP levels and reduced pruritus significantly. The drug is available in 10mg capsules and is under review by the EMA and UK MHRA.
FDA grants accelerated approval for Livdelzi (seladelpar) for treating primary biliary cholangitis (PBC) in adults, either with ursodeoxycholic acid (UDCA) for inadequate response or as monotherapy for those unable to tolerate UDCA. The approval is based on a Phase 3 study showing 62% of Livdelzi-treated participants achieved a composite biochemical response at month 12, compared to 20% on placebo. Livdelzi led to ALP normalization in 25% of participants, a significant reduction in pruritus, and no treatment-related serious adverse events.
FDA grants Gilead Sciences' Livdelzi (seladelpar) accelerated approval for treating PBC in adults intolerant or unresponsive to UDCA. Livdelzi, a PPAR delta agonist, showed significant improvement in liver disease markers and reduced pruritus in the RESPONSE study, with potential for continued approval pending further trials.