Lerodalcibep can be a treatment option for patients requiring additional LDL-C reduction: GlobalData
Lerodalcibep is a novel therapy designed to lower low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD)
LIB Therapeutics (LIB) recently announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel therapy designed to lower low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD) or those at high or very high risk of developing ASCVD. If approved, lerodalcibep could be a key treatment option for patients needing additional LDL-C reduction beyond existing therapies, says GlobalData,
Lerodalcibep is a third-generation proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor developed to treat hypercholesterolemia, particularly for patients with complex conditions like HeFH and those who fail to achieve adequate cholesterol reduction with statins alone.
Dr Shireen Mohammad, Senior Cardiovascular and Metabolic Disorders Analyst, GlobalData, comments, “Lerodalcibep, like established PCSK9 inhibitors such as Regeneron’s Praluent (alirocumab) and Amgen’s Repatha (evolocumab), targets the PCSK9 protein to help reduce LDL-C levels. However, it distinguishes itself with its unique design as a long-acting bispecific monoclonal antibody, which may provide an added advantage over existing treatments for dyslipidemia. Lerodalcibep offers the convenience of a once-monthly injection, reducing the dosing frequency compared to many other PCSK9 inhibitors.”
Key opinion leaders (KOLs) interviewed by GlobalData have noted that patients often prefer a once-monthly injection over daily pills, as it is more convenient and reduces the burden of daily medication, potentially improving adherence for life-long therapy needed in HeFH.
Mohammad concludes, “The FDA’s acceptance of the BLA marks a milestone for LIB Therapeutics in its pursuit of innovative lipid-lowering treatments. Submitted to the FDA in late 2024, the BLA is supported by data from multiple Phase 3 clinical trials assessing the efficacy and safety of lerodalcibep. This regulatory acceptance advances lerodalcibep into the FDA’s review process, bringing it closer to potential approval and offering hope for patients struggling to achieve their LDL-C goals despite existing treatments.”
