Prescribing information (external link)
LEQVIO® (inclisiran) is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:1
in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low-density lipoprotein cholesterol (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 (SmPC).
LEQVIO® (inclisiran)
LEQVIO® is recommended by NICE, within its licensed indications, as an option for the treatment of eligible adult patients who:2
Have already had certain cardiovascular (CV) events (acute coronary syndrome such as myocardial infarction [MI] or unstable angina needing hospitalisation, coronary or other arterial revascularisation procedures, coronary heart disease, ischaemic stroke or peripheral artery disease)
Have persistently elevated LDL-C levels (≥2.6 mmol/L) despite maximum tolerated statins with or without other lipid-lowering therapies, or other lipid-lowering therapies when statins are not tolerated or are contraindicated
Nearly 1 in 5 (18.3%) patients who suffer an MI experience another CV event within 1 year*3
The effect of LEQVIO® on cardiovascular morbidity and mortality has not yet been determined.1
LEQVIO® lowers LDL-C by ~50% from baseline in as little as 3 months, and maintains it between 6-monthly injections in patients on a maximally tolerated statin†4,5
LEQVIO® has a safety profile comparable to placebo, with injection-site reactions being the only reported adverse event (8.2% vs 1.8% with placebo)1,5
After an initial dose, LEQVIO® is administered again at 3 months followed by a dose every 6 months1
For full prescribing information, please refer to the LEQVIO® SmPC.
Resource
LEQVIO®: A practical guide
Your Guide to LEQVIO®
A quick-guide to LEQVIO®, with information on NICE guidance and the NHS commercial agreement through to dosing and administration.
*Based on a retrospective cohort study of patients with primary MI between July 2006 and June 2011 from Swedish national registries. The MI population consisted of 97,254 patients who were alive 1 week after discharge.3
†In ORION-10, the baseline mean (±SD) LDL-C levels were 2.70±1.02 mmol/L with LEQVIO® and 2.71±0.96 mmol/L with placebo. At Month 17, LEQVIO® delivered placebo-corrected LDL-C reductions of 52.3%, as compared with baseline (−51.3% with LEQVIO® vs +1.0% with placebo; 95% CI: –55.7 to −48.8; p<0.001; co-primary endpoint), with a time-adjusted LDL-C reduction of 53.8% (−51.3% with LEQVIO® vs +2.5% with placebo; 95% CI: −56.2 to −51.3; p<0.001) from baseline between Months 3 and 18 relative to placebo (co-primary endpoint).5
CV, cardiovascular; LDL-C, low-density lipoprotein cholesterol; MI, myocardial infarction; NICE, National Institute for Health and Care Excellence; SD, standard deviation; SmPC, summary of product characteristics.
References
LEQVIO® Summary of Product Characteristics.
National Institute for Health and Care Excellence. Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia. Available at: https://www.nice.org.uk/guidance/ta733/resources/inclisiran-for-treating-primary-hypercholesterolaemia-or-mixed-dyslipidaemia-pdf-82611252825541 [Accessed April 2026].
Jernberg T, et al. Eur Heart J 2015;36:1163–1170.
Landmesser U, et al. Eur Heart J 2025:ehaf68.
Ray KK, et al. N Engl J Med 2020;382:1507–1519.
LEQVIO® and the LEQVIO® logo are registered trademarks of Novartis AG. Licensed from Alnylam Pharmaceuticals, Inc.
UK | April 2026 | FA-11561351-1
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.
