Inclisiran is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- 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.1
Inclisiran is the first and only siRNA LDL-C-lowering therapy1,3,4
Later this year, subject to a positive NICE appraisal, a proposed pioneering collaboration between Novartis and NHS England is set to use a population health approach to offer treatment to a large at-risk ASCVD patient population5
Inclisiran delivered effective and sustained LDL-C reduction, in combination with a maximally tolerated statin, in patients with ASCVD (or risk equivalents)‡§2
Inclisiran was generally well-tolerated in three Phase III trials, with a safety profile similar to placebo apart from injection-site reactions, which were more common in the inclisiran group2,6
For further information please refer to the Summary of Product Characteristics by clicking here
Inclisiran is not yet available to prescribe in the UK.
‡ At Month 17, inclisiran delivered placebo-corrected LDL-C reductions of 52%, as compared with baseline (95% CI: −55.7 to −48.8; P<0.0001) in ORION-10, and of 50%, as compared with baseline (95% CI: −53.1 to −46.6; P<0.0001) in ORION-11, with respective time-adjusted LDL-C reductions of 54% (95% CI: −56.2 to −51.3; P<0.0001) and of 49% (95% CI: −51.6 to −46.8; P<0.0001) from baseline between Months 3 and 18 relative to placebo.1,2
§ ASCVD was defined as coronary heart disease, cerebrovascular disease or peripheral arterial disease.7 ASCVD risk equivalents included type 2 diabetes, FH, or a 10-year risk of a cardiovascular event of ≥20% as assessed by the Framingham Risk Score for Cardiovascular Disease or equivalent.2
ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; FH, familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; siRNA, small interfering ribonucleic acid.
- Leqvio® Summary of Product Characteristics.
- Ray KK et al. N Engl J Med 2020;[382(16):1507–1519.]
- Stoekenbroek RM et al. Future Cardiol 2018;14(6):433–442.
- Klinovski M et al. CADTH Issues in Emerging Health Technologies, 2019. Canadian Agency for Drugs and Technologies in Health.
- Gov.uk. New heart disease drug to be made available for NHS patients. Available at: https://www.gov.uk/government/news/new-heart-disease-drug-to-be-made-ava... [Accessed: January 2021].
- Raal FJ et al. N Engl J Med 2020;382(16):1520–1530.
- Ray KK et al. N Engl J Med 2020;382(16):1507–1519 (trial protocols).