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Prescribing information

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LEQVIO® (inclisiran) showed placebo-adjusted LDL-C reductions of ~50% on average, on top of a maximally tolerated dose of statin*1

LEQVIO® (inclisiran) is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2

  • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or

  • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated

For full safety information, please refer to the LEQVIO® Summary of Product Characteristics.

LEQVIO® efficacy

The efficacy and safety profile of LEQVIO®, compared with placebo, was characterised in the ORION-10 and -11 studies in patients with ASCVD (or ASCVD risk equivalents)†1

Patients on maximally tolerated statin were nearly 5x more likely to achieve an LDL-C of less than 2.0 mmol/L when LEQVIO® was added in than with statins and placebo*1

After an initial dose, LEQVIO® is administered again at 3 months, followed by every 6 months.2

Using LEQVIO® first when statins alone are not enough may help bring the study target of 1.8 mmol/L LDL-C within reach for eligible patients*1

In clinical trials, LEQVIO® had a safety profile similar to placebo, apart from injection site reactions (8.2% vs 1.8% with placebo).2

Adverse events across ORION-10 and ORION-11 trials:

LEQVIO® was generally well tolerated with a safety profile similar to placebo apart from injection-site reactions.1

Injection-site adverse reactions were more frequent with LEQVIO® than placebo:1

  • ORION-10: 2.6% (n=20) vs 0.9% (n=7), respectively

  • ORION-11: 4.7% (n=38) vs 0.5% (n=4), respectively

The majority of these reactions were mild, with none being severe or persistent:1

Discontinuation rates due to adverse events were balanced among both treatment groups:1

  • 2.4% (n=19) vs 2.2.% (n=17) in ORION-10, of patients treated with LEQVIO® and placebo, respectively

  • 2.8% (n=23) vs 2.2% (n=18) in ORION-11, of patients treated with LEQVIO® and placebo, respectively

Laboratory results were similar in the LEQVIO® and placebo groups in each trial:1

  • With respect to liver and kidney function, levels of creatine kinase and high-sensitivity C-reactive protein, and platelet count were also similar in the LEQVIO® and placebo groups in each trial

The effect of LEQVIO® on cardiovascular morbidity and mortality has not yet been determined.2

For ORION-10 and ORION-11 safety data, please click here.

*Data from the multicentre, double-blind, randomised, placebo-controlled, 18-month ORION-10 (N=1561) and ORION-11 (N=1617) clinical trials evaluating adult patients on a maximally tolerated statin with ASCVD, and with ASCVD or risk equivalents, respectively. The mean (±SD) LDL cholesterol levels at baseline in the ORION-10 and ORION-11 trials were 104.7±38.3 mg/dL (2.7±0.99 mmol/L) and 105.5±39.1 mg/dL (2.73±1.01 mmol/L), respectively. The proportion of patients achieving an LDL-C goal of 1.8 mmol/L at Month 17 with LEQVIO® vs placebo was 74% vs 15% in ORION-10 (19.2;14.7–25.2), and 81% vs 18% in ORION-11 (17.1;13.2–22.0). At Month 17, LEQVIO® delivered placebo-corrected LDL-C reductions of 52%, as compared with baseline (−51% with LEQVIO® vs +1% with placebo; 95% CI: −55.7 to −48.8; p<0.001) in ORION-10, and of 50%, as compared with baseline (−46% with LEQVIO® vs +4% with placebo; 95% CI: −53.1 to −46.6; p<0.001) in ORION-11, with respective time-adjusted LDL-C reductions of 54% (−51% with LEQVIO® vs +3% with placebo; 95% CI: −56.2 to −51.3; p<0.001) and of 49% (−46% with LEQVIO® vs +3% with placebo; 95% CI: −51.6 to −46.8; p<0.001) from baseline between Months 3 and 18 relative to placebo.1
†ASCVD risk equivalents included type 2 diabetes, HeFH, or a 10-year risk of a cardiovascular event of ≥20% as assessed by the Framingham Risk Score for Cardiovascular Disease or equivalent.1

ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; HDL, high-density-lipoprotein; HeFH, heterozygous familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol, PCSK9, proprotein convertase subtilisin/kexin type 9; SD, standard deviation.

References

  1. Ray KK, et al. N Engl J Med 2020;382(16):1507–1519 and supplementary appendix.

  2. LEQVIO® Summary of Product Characteristics. Available at: www.medicines.ie.

LEQVIO® and the LEQVIO® logo are registered trademarks of Novartis AG. Licensed from Alnylam Pharmaceuticals, Inc.

IE11496814-1 | April 2026

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported to HPRA Pharmacovigilance at www.hpra.ie. Adverse events can also be reported to Novartis preferably at www.novartis.com/report, by emailing [email protected] or by calling (01) 2080 612.