LIB Therapeutics launches Lerochol in the United States after FDA approval

LIB Therapeutics Inc. announced the U.S. commercial launch of LEROCHOL® (lerodalcibep-liga) Injection 300 mg/1.2 mL, a once-monthly, self-administered third-generation PCSK9 inhibitor. LEROCHOL is FDA approved as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

The launch features a direct-to-patient cash-pay option priced at $199 per month, a substantial discount to other PCSK9 inhibitor cash prices. LEROCHOL is now available in a prefilled syringe, and the company expects FDA approval of LEROCHOL in an auto-injector pen later this year.

The FDA approval of Lerochol was based on data from the global Phase 3 LIBerate Clinical Trial Program, which enrolled a diverse population of over 2,900 patients with cardiovascular disease, without cardiovascular disease at very high and high risk for cardiovascular disease, including heterozygous and homozygous familial hypercholesterolemia. Lerodalcibep was dosed once monthly for up to 52 weeks in placebo-controlled trials, and over 2,400 patients continued in the 72-week open-label extension trial.

In clinical trials, Lerochol demonstrated sustained LDL-C reductions of ≥60% in patients with, or at very high or high risk of, cardiovascular disease and ≥50% in those with HeFH who have more severe LDL-C elevations. Lerochol was generally well tolerated across the LIBerate Clinical Trial Program, with no treatment-related serious adverse events reported in the long-term extension studies.

LEROCHOL is different from other PCSK9 inhibitors because it is the only one with once-monthly, single injection, self-administered dosing. It is a small-binding protein, not a monoclonal antibody, and offers extended room temperature stability for up to three months.

The most commonly occurring adverse reactions in clinical trials in primary hyperlipidemia in adults, including HeFH, were nasopharyngitis (15% and 14% versus placebo), local injection site reactions (12% and 5% versus placebo) and peripheral edema (2% and <1% versus placebo). In clinical trials in HeFH, the most commonly occurring adverse reactions were injection site reactions (18% and 3% versus placebo), nasopharyngitis (13% and 9% versus placebo), diarrhea (3% and 1% versus placebo), nausea (2% and 0% versus placebo) and peripheral edema (2% and <1% versus placebo). The most frequent adverse reaction leading to treatment discontinuation in trials in primary hypercholesterolemia in adults was injection site reactions, with a higher frequency in the LEROCHOL-treated group compared to placebo-treated patients (1% vs. 0%).

Lerochol is expected to be available in the United States as a pre-filled syringe in the spring of 2026 with an upgraded autoinjector device expected later in the year.