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Everest Medicines Announces that Licensing Partner LIB Therapeutics has Received U.S. FDA Approval of LEROCHOL™ (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved LEROCHOL™ (lerodalcibep-liga) injection from LIB Therapeutics, for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, includin
About this update from Everest Medicines Ltd.
[{"type":"text","content":"SHANGHAI, Dec. 17, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved LEROCHOL™ (lerodalcibep-liga) injection from LIB Therapeutics, for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Everest has exclusive rights to develop, register and commercialize Lerodalcibep ("LEROCHOL") in Greater China.","length":734,"tagName":"p"},{"type":"text","content":"LEROCHOL is a novel, third-generation PCSK9 inhibitor designed to help patients achieve and maintain their LDL-C targets. It is self-administered as a once-monthly, single small-volume subcutaneous injection with extended room-temperature stability (up to 3 months), giving patients the freedom to administer it where and when they choose. These features make LEROCHOL a unique alternative to other PCSK9 inhibitors.","length":416,"tagName":"p"},{"type":"text","content":"The FDA approval of LEROCHOL was based on data from the comprehensive global Phase 3 LIBerate Clinical Trial Program, which enrolled a diverse population of over 2,900 patients with cardiovascular disease (CVD), or without but at very high or high risk for CVD, including HeFH.","length":277,"tagName":"p"},{"type":"text","content":"In clinical trials, LEROCHOL demonstrated sustained LDL-C reductions of ≥60% in patients with, or at very-high or high risk of CVD and 59% in those with HeFH who have more severe LDL-C elevations. LEROCHOL was generally well tolerated across the LIBerate Clinical Trial Program. Lerodalcibep is expected to expand treatment options for millions of patients around the world with CVD, including the 30 million individuals with FH.","length":429,"tagName":"p"},{"type":"text","content":"CVD remains the leading cause of death globally and in China, and lower LDL-C levels have been demonstrated to lead to better outcomes. Despite the availability of statins and other lipid-lowering therapies, millions of patients with or at risk of CVD, including those with FH, fail to achi...