FDA Approves Lerochol (lerochol) for Hypercholesterolemia to Reduce LDL-CFDA approves new monthly shot Lerochol to lower cholesterol

Lerochol is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor. It reduces LDL-C by inhibiting PCSK9, thereby increasing the number of LDL receptors available to clear LDL from the blood.

Lerochol is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

The recommended dosage is 300 mg administered subcutaneously once monthly. Inject into the abdomen or thigh; a caregiver or healthcare professional may administer into the upper arm. If a dose is missed by less than 7 days, administer as soon as possible and resume the original schedule. If missed by 7 or more days, administer as soon as possible and start a new monthly schedule. Allow the prefilled syringe to warm to room temperature (up to 25°C/77°F) for at least 30 minutes before use. Inspect the solution; it should be clear to slightly opalescent, brownish-yellow to amber. Do not use if cloudy or containing particles. Do not inject into tender, bruised, red, or indurated skin. Rotate injection sites. Push plunger fully to deliver the entire 300 mg dose.

Efficacy was evaluated in three randomized, double-blind, placebo-controlled trials (Trial 1, Trial 2, and a third trial) enrolling 2,017 adults with HeFH, clinical ASCVD, or increased risk for ASCVD, all on maximally tolerated statin therapy. In Trial 1 (NCT04797247), 1,844 adults were randomized 2:1 to Lerochol 300 mg or placebo every 4 weeks for 52 weeks. The primary endpoint was placebo-adjusted percent change in LDL-C from baseline to Week 52. The difference was -55% (95% CI: -59.2%, -50.8%; p < 0.0001). Baseline characteristics: mean age 64 years, 30% female, mean baseline LDL-C 102 mg/dL. Trial 2 (NCT04806893) had similar design with mean age 65 years, 45% female, mean baseline LDL-C 116 mg/dL. Additional lipid parameters (total cholesterol, non-HDL-C, ApoB) were also improved. Detailed results for Trial 2 and the third trial are not fully presented in the label.

No specific warnings or contraindications are detailed in the provided label text.

Lerochol is a PCSK9 inhibitor for adults with hypercholesterolemia, including HeFH, who require additional LDL-C lowering despite maximally tolerated statin therapy. It offers a once-monthly subcutaneous dosing option. Clinicians should consider it for patients who need further LDL-C reduction, but should be aware that long-term outcomes data are not provided in the label.