LIB Therapeutics announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lerodalcibep, a treatment aimed at lowering low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD), or those at very high or high risk of ASCVD. The application also includes individuals with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), and patients aged ten years or older with homozygous familial hypercholesterolemia. The BLA was submitted to the FDA in late 2024, supported by data from multiple Phase III clinical trials assessing the efficacy and safety of lerodalcibep.
Lerodalcibep is a third-generation proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor developed to treat hypercholesterolemia, particularly for patients with complex conditions such as HeFH and those who fail to achieve adequate cholesterol reduction with statins alone. Like monoclonal antibodies, lerodalcibep binds to PCSK9, blocking its interaction with LDL receptors (LDLRs). This prevents LDLR degradation, promotes LDLR recycling, enhances LDL-C clearance, and reduces LDL-C levels. As a result, lerodalcibep effectively targets a critical pathway in cholesterol regulation.
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Lerodalcibep, like established PCSK9 inhibitors such as Regeneron’s Praluent and Amgen’s Repatha, 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 interviewed by leading data and analytics company 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.
The FDA’s acceptance of the BLA marks a milestone for LIB Therapeutics in its pursuit of innovative lipid-lowering treatments. If approved, lerodalcibep could be a key treatment option for patients needing additional LDL-C reduction beyond existing therapies. This regulatory acceptance advances lerodalcibep in the FDA’s review process, bringing it closer to approval and offering hope for patients struggling to achieve their LDL-C goals despite existing treatments.
