The FDA has approved LIB Therapeutics’ Lerochol (lerodalcibep-liga), a once-monthly, subcutaneously administered proprotein convertase subtilisin / kexin type 9 (PCSK9) inhibitor, for use as an adjunct to diet and exercise in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).
The approval is based on results from the Phase III LIBerate programme, which enrolled over 2,900 high-risk patients, such as those with established cardiovascular disease and HeFH. In the pivotal LIBerate-004 study, once-monthly Lerochol reduced low-density lipoprotein cholesterol (LDL-C) by approximately 60% versus placebo and enabled nearly 70% of HeFH patients to reach guideline LDL-C targets. The drug also lowered apolipoprotein B by about 50% and lipoprotein(a) by about 25%, was generally well tolerated, and showed no treatment-related serious adverse events, with injection-site reactions the main reason for discontinuation.
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Lerochol is a third-generation PCSK9 inhibitor designed for convenience, with once-monthly self-administration, a small injection volume, and room-temperature stability for up to three months. These features may help overcome some of the challenges associated with currently marketed injectable PCSK9 therapies. Compared with the oral PCSK9 inhibitors that are in development, which generally require daily dosing and fasting, Lerochol’s monthly dosing schedule could offer a simpler option for patients who need long-term, intensive LDL-C reduction.
Despite current treatments with statins, ezetimibe, and existing PCSK9 inhibitors, many patients with HeFH or very high cardiovascular risk still do not meet LDL-C goals. The approval of Lerochol expands the PCSK9 inhibitor class and provides an additional option for patients who need more intensive LDL-C lowering or remain insufficiently controlled on current therapies.
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