The US Food and Drug Administration (FDA) has approved an autoinjector formulation of lerodalcibep-liga (LEROCHOL), a third-generation PCSK9 inhibitor, according to LIB Therapeutics, Inc.1
Frequently Asked Questions
What is lerodalcibep-liga approved for?
Lerodalcibep-liga is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including HeFH, with a label now reflecting MACE risk reduction achieved through LDL-C lowering with statins or add-on PCSK9 inhibitor therapy.
How does the lerodalcibep-liga autoinjector work?
The autoinjector is a single-use, pressure-activated device delivering the standard once-monthly 300 mg/1.2 mL dose of lerodalcibep-liga in a single motion completed in seconds.
What did the LIBerate program show?
In the Phase 3 LIBerate program, lerodalcibep-liga produced sustained LDL-C reductions of 60% or more in patients with, or at high risk for, cardiovascular disease, and 59% or more in patients with HeFH.
The single-use device delivers the existing once-monthly, 300 mg/1.2 mL dose via a pressure-activated, single-motion injection completed in seconds. The agency also approved an updated indication statement for lerodalcibep-liga reflecting the established reduction in major adverse cardiovascular events (MACE) achieved through LDL-C lowering in adults with hypercholesterolemia treated with statins or with monoclonal antibody PCSK9 inhibitors added to statin therapy.1
"PCSK9 inhibitors have been one of the most important advances in cardiovascular medicine of the last 20 years. However, a patient only gets benefit from the lower and sustained LDL-C levels these medications provide if they stay on treatment," Dean J. Kereiakes, MD, FACC, MSCAI, Chairman of The Christ Hospital Heart and Vascular Institute and professor of medicine at the University of Cincinnati, said in a statement. “As much as patients expect highly efficacious and safe therapies, they need therapies that fit into their busy lifestyles, and LEROCHOL provides a compelling option on both counts.”1
Lerodalcibep-liga has already differentiated itself among PCSK9 inhibitors through once-monthly self-administration and room-temperature stability of up to 90 days, distinguishing it from agents requiring refrigeration or more frequent dosing. The autoinjector adds a second administration option alongside the existing pre-filled syringe, without altering the dose or interval. Lerodalcibep-liga launched in the United States in May 2026, and the updated indication statement now aligns its labeling with class-wide evidence linking LDL-C lowering to reduced cardiovascular risk.1,2
The FDA approval of the autoinjector builds on the original approval basis: the Phase 3 LIBerate Clinical Trial Program, described by LIB Therapeutics as a comprehensive global registration effort. The program enrolled >2,900 patients across cardiovascular disease, high and very high cardiovascular risk without established disease, and heterozygous and homozygous familial hypercholesterolemia (HeFH) populations. Patients received lerodalcibep-liga once monthly for up to 52 weeks in the placebo-controlled registration trials, and >2,400 patients continued into a 72-week open-label extension.1,2
According to the company, lerodalcibep-liga produced sustained LDL-C reductions of 60% or more in patients with, or at very high or high risk for, cardiovascular disease, and reductions of 59% or more in patients with HeFH. The autoinjector delivers the same dose as the pre-filled syringe in a device designed for quick self-administration, and does not require overnight fasting or timing around food or oral medications.1
Lerodalcibep safety profile and updated MACE indication
Safety data cited in the release reflect adverse event rates from the LIBerate program's placebo-controlled trials. In studies of primary hyperlipidemia, including HeFH, injection site reactions occurred in 12% of lerodalcibep-liga-treated patients compared with 5% of placebo patients, and nasopharyngitis occurred in 15% versus 14%, respectively. In trials restricted to patients with HeFH, injection site reactions occurred in 18% of treated patients versus 3% with placebo, alongside nasopharyngitis (13% vs 9%), diarrhea (3% vs 1%), nausea (2% vs 0%), and peripheral edema (2% vs <1%).1
Injection site reactions were also the most frequent adverse reaction leading to discontinuation, occurring in 1% of lerodalcibep-liga-treated patients versus none of the placebo group. LIB Therapeutics reports no serious treatment-related adverse events in the long-term, 72-week open-label extension study. The updated indication statement now explicitly references MACE risk reduction achieved through LDL-C lowering with statins or with monoclonal antibody PCSK9 inhibitors used as add-on therapy to statins, aligning lerodalcibep-liga's label with the broader PCSK9 inhibitor class.1
LIB Therapeutics has also submitted a Marketing Authorization Application to the European Medicines Agency, with anticipated approval in the second half of 2026, and a Biologics License Application in Greater China, with potential approval in 2027. The company plans to pursue additional regulatory submissions in other markets. LIB expects the autoinjector to be available in the United States by January 2027, at the same $199 monthly direct-to-patient cash price as the pre-filled syringe.1
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