LEQVIO® 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 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®▼ (inclisiran)
LEQVIO® is recommended by NICE, within its licensed indication, as an option for the treatment of eligible adult patients who:2
Have already had certain cardiovascular events (acute coronary syndrome such as MI or unstable angina needing hospitalisation, coronary or other arterial revascularisation procedures, coronary heart disease, ischaemic stroke or PAD)
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 patients with cardiovascular disease do not have a recorded current prescription of lipid-lowering therapy, remaining at high risk for cardiovascular events and death (n=472,650)*3
The effect of LEQVIO® on cardiovascular morbidity and mortality has not yet been determined.1
On average, LDL-C levels were reduced by ~50% from baseline (2.92±1.2 mmol/L) in eligible patients with ASCVD on LEQVIO® and a maximally tolerated statin in an observational study, which is consistent with the placebo-corrected results seen in the Phase III trials ORION-9, ORION-10 and ORION-114–7
In clinical trials, LEQVIO® had a safety profile similar to placebo, apart from injection-site reactions (8.2% and 1.8% of patients, respectively)1
*National CVDPREVENT data covering the period up to March 2022. Data was received from 96.6% of GP practices, including approximately 18 million patients.3
ASCVD, atherosclerotic cardiovascular disease; GP, general practitioner; LDL-C, low-density lipoprotein cholesterol; NICE, National Institute for Health and Care Excellence.
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... [Accessed January 2025].
Healthcare Quality Improvement Partnership. https://www.hqip.org.uk/resource/third-annual-report-cvdprevent/ [Accessed January 2025].
Wright RS, et al. Oral presentation. ORION-8: Long-term efficacy and safety of twice-yearly inclisiran in high cardiovascular risk patients. ESC Congress 2023. Amsterdam, The Netherlands, 25–28 August 2023.
Raal FJ, et al. N Engl J Med 2020;382:1520–1530.
Ray KK, et al. N Engl J Med 2020;382:1507–1519.
Ray KK, et al. Eur Heart J 2022;43(48):5047–5057.
LEQVIO® and the LEQVIO® logo are registered trademarks of Novartis AG. Licensed from Alnylam Pharmaceuticals, Inc.
UK | January 2025 | FA-11205529
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.