FDA Approves Lerodalcibep Autoinjector for Hypercholesterolemia, Updated Indication

The US Food and Drug Administration (FDA) has approved an autoinjector device for lerodalcibep-liga (Lerochol), a third-generation PCSK9 inhibitor for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH), according to a release from LIB Therapeutics.¹

The agency also approved an updated indication statement reflecting the established reduction in major adverse cardiovascular events (MACE) achieved through LDL-C lowering with statins or monoclonal antibody PCSK9 inhibitors added to statin therapy.¹ The autoinjector is expected to launch in the United States by January 2027 alongside the previously approved pre-filled syringe.

“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 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. [Lerodalcibep] provides substantial LDL-C reduction that achieves the 2026 lipid guidelines in the vast majority of my patients with minimal inconvenience. My patients really appreciate having only once-monthly dosing with [lerodalcibep], and now the availability of the autoinjector further simplifies this important treatment option.”

Lerodalcibep first reached the US market earlier in 2026 as a once-monthly, self-administered injection delivered via pre-filled syringe.² The updated label brings lerodalcibep’s indication language in line with other approved PCSK9 inhibitors, aligning cardiovascular outcomes data across the drug class.¹ Long-term adherence has remained a persistent barrier among patients on PCSK9 inhibitors, and the autoinjector option is designed to address it.

Lerodalcibep-liga LIBerate Trial Program Design and LDL-C Efficacy

The FDA approval of the lerodalcibep autoinjector and updated indication rests on the phase 3 LIBerate Clinical Trial Program. The program enrolled more than 2900 patients with cardiovascular disease (CVD), without CVD but at very high or high risk for CVD, and with heterozygous or homozygous familial hypercholesterolemia.¹ Patients received lerodalcibep once monthly for up to 52 weeks in the placebo-controlled registration trials, with more than 2400 patients continuing into a 72-week open-label extension study.¹

Lerodalcibep-liga produced sustained LDL-C reductions of at least 60% among patients with, or at very high or high risk of, cardiovascular disease.¹ Patients with HeFH, who typically present with more severe LDL-C elevations, achieved LDL-C reductions of at least 59%.¹ LIB Therapeutics reported the agent was generally well tolerated across the program, with no serious treatment-related adverse events in the long-term extension studies.¹

Lerodalcibep Safety Profile and Autoinjector Device Details

In trials among adults with primary hyperlipidemia, including HeFH, the most common adverse reactions occurring in at least 2% of patients and more frequently than with placebo were nasopharyngitis (15% vs 14%), local injection site reactions (12% vs 5%), and peripheral edema (2% vs <1%).¹ Among patients with HeFH specifically, the most common reactions were injection site reactions (18% vs 3%), nasopharyngitis (13% vs 9%), diarrhea (3% vs 1%), nausea (2% vs 0%), and peripheral edema (2% vs <1%).¹

Injection site reactions were the most frequent adverse reaction leading to discontinuation, occurring in 1% of lerodalcibep-liga-treated patients compared with 0% of patients on placebo. As a recombinant fusion protein, lerodalcibep-liga carries a potential for immunogenicity, consistent with other therapeutic proteins in its class. The newly approved autoinjector is a single-use, pressure-activated device designed to deliver a complete dose in seconds with a single motion, and lerodalcibep can now be stored at room temperature for up to 90 days.¹

LIB Therapeutics described plans to launch the lerodalcibep autoinjector in the United States by January 2027, with insurance coverage expected to expand gradually over the course of 2027. 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 2027.¹

“Innovation in PCSK9 inhibition cannot stop at the molecule, because how a medicine for life-long therapy fits into a patient’s life is what determines whether they stick with it over the long haul,” said Kristen Miller, Vice President, Brand Communications, LIB Therapeutics. “The monthly dosing by autoinjector is completed in seconds, does not interfere with any oral medications, require overnight fasting, or limit the timing of food and beverage consumption. These features, along with the extended room temperature storage, mean LEROCHOL fits into patients’ lives and not the other way around.”

References:

1. LIB Therapeutics. U.S. Food and Drug Administration approves an autoinjector version of LEROCHOL (lerodalcibep-liga) and updated indication. Published August 17, 2026. Accessed August 17, 2026. https://www.businesswire.com/news/home/20260817106971/en/U.S.-Food-and-Drug-Administration-Approves-an-Autoinjector-Version-of-LEROCHOL-lerodalcibep-liga-and-Updated-Indication

2. LIB Therapeutics. LEROCHOL (lerodalcibep-liga) prescribing information. Accessed August 17, 2026. https://lerochol.com/