FDA Approval

FDA Approves Lerochol Autoinjector for Adults With Hypercholesterolemia, Updates LDL-C Labeling

Edited by:
Anthony Calabro, MA

Key Highlights

  • The FDA approved an autoinjector for lerodalcibep-liga (Lerochol) 300 mg/1.2 mL for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
  • The approval was based on the phase 3 LIBerate clinical trial program, which enrolled more than 2,900 patients and included placebo-controlled trials.
  • Lerodalcibep produced sustained LDL-C reductions of at least 60% in patients with or at very high or high risk for cardiovascular disease and at least 59% in patients with HeFH.
  • Injection-site reactions were among the most reported adverse reactions and were the most frequent adverse reaction leading to treatment discontinuation in trials of adults with primary hypercholesterolemia.

On August 17, 2026, the FDA approved an autoinjector version of lerodalcibep-liga 300 mg/1.2 mL (Lerochol, LIB Therapeutics, Inc) and an update to its prescribing information.

Lerodalcibep, a PCSK9 inhibitor, is indicated 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 updated prescribing information states that cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events in adults at increased risk when treated with statins or monoclonal antibody PCSK9 inhibitors as an add-on to statin therapy.

FDA approval of lerodalcibep was based on the global phase 3 LIBerate clinical trial program, which enrolled more than 2,900 patients with cardiovascular disease, patients without cardiovascular disease who were at very high or high cardiovascular risk, and patients with heterozygous or homozygous familial hypercholesterolemia. Lerodalcibep was administered once monthly for up to 52 weeks in placebo-controlled registration trials, and more than 2,400 patients continued into a 72-week open-label extension study. Across the program, sustained LDL-C reductions of at least 60% were reported among patients with cardiovascular disease or at very high or high cardiovascular risk. In comparison, reductions of at least 59% were reported among patients with HeFH. The press release did not specify a primary efficacy endpoint.

Among adults with primary hyperlipidemia, including HeFH, commonly reported adverse reactions with lerodalcibep included nasopharyngitis (15% vs 14% with placebo), local injection-site reactions (12% vs 5%), and peripheral edema (2% vs <1%). In HeFH trials, injection-site reactions occurred in 18% of patients receiving lerodalcibep compared with 3% receiving placebo. Injection-site reactions were the most frequent adverse reaction, leading to treatment discontinuation in primary hypercholesterolemia trials (1% vs 0%).

Lerodalcibep is administered as a 300-mg/1.2-mL subcutaneous injection once monthly. The single-use, pressure-activated autoinjector is intended for patient self-administration and can be stored at room temperature for up to 90 days. The prefilled syringe remains available, and the autoinjector is expected to become available in the United States by January 2027.

Reference
LIB Therapeutics, Inc. U.S. Food and Drug Administration approves an autoinjector version of Lerochol (lerodalcibep-liga) and updated indication. Business Wire. Published August 17, 2026. Accessed August 19, 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