Overview
Leqvio is a medicine used to reduce cholesterol in the blood. It is used in adults with primary hypercholesterolaemia or mixed dyslipidaemia (conditions that cause high levels of fats, including cholesterol, in the blood). It should be used with a low-fat diet.
Leqvio is used in combination with a statin (a type of cholesterol-lowering medicine) when the maximum dose of the statin does not lower cholesterol levels enough. It can also be used in combination with other cholesterol-lowering medicines in patients who cannot take a statin.
Leqvio contains the active substance inclisiran.
Leqvio is given by injection under the skin, usually in the belly but also in the upper arm or thigh. After the first injection, the next dose is given after 3 months and then it is given every 6 months.
The medicine can only be obtained with a prescription. For more information about using Leqvio, see the package leaflet or contact your doctor or pharmacist.
Inclisiran, the active substance in Leqvio, interferes with RNA (genetic material) to limit the production of PCSK9, a protein that can increase levels of LDL-cholesterol (‘bad’ cholesterol). By preventing PCSK9 production, Leqvio helps to lower LDL-cholesterol levels.
Three main studies involving a total of 3,660 patients found Leqvio effective at lowering levels of LDL-cholesterol. Over 94% of patients in the studies were also taking statins or other medicines to lower the levels of lipids (fats) in blood.
The studies included patients with a form of hypercholesterolaemia that runs in families and patients with raised LDL-cholesterol who either had atherosclerotic cardiovascular disease (where fatty deposits have built up in blood vessels) or were prone to atherosclerotic cardiovascular disease. After 510 days (around 15 months), the results were similar for all studies, and overall, LDL-cholesterol had dropped by over 50% in patients treated with Leqvio compared with those receiving placebo (a dummy treatment).
The most common side effects with Leqvio (which may affect up to 1 in 10 people) are reactions such as pain, redness and rash at the injection site.
For the full list of side effects and restrictions of Leqvio, see the package leaflet.
Studies have found worthwhile reductions in LDL-cholesterol levels in patients treated with Leqvio, which go beyond reductions attained with statins or other lipid-lowering medicines. There is no direct evidence yet that Leqvio reduces heart attacks or stroke but reduction in LDL-cholesterol is linked to reduction in atherosclerotic cardiovascular disease. The side effects of Leqvio are manageable.
The European Medicines Agency therefore decided that Leqvio’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Leqvio have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Leqvio are continuously monitored. Side effects reported with Leqvio are carefully evaluated and any necessary action taken to protect patients.
Leqvio received a marketing authorisation valid throughout the EU on 09 December 2020.
Leqvio : EPAR - Medicine overview
Reference Number: EMA/561767/2020
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Leqvio : EPAR - Risk-management-plan summary
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Product information
Leqvio : EPAR - Product information
English (EN) (612.03 KB - PDF)
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български (BG) (768.79 KB - PDF)
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latviešu valoda (LV) (722.05 KB - PDF)
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lietuvių kalba (LT) (772.53 KB - PDF)
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magyar (HU) (765.68 KB - PDF)
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Latest procedure affecting product information: II/0022
19/04/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics(annex I);
- manufacturing authorisationholder responsible for batch release (annex IIA);
- conditions of themarketing authorisation(annex IIB);
- labelling(annex IIIA);
- package leaflet(annex IIIB).
Leqvio : EPAR - All authorised presentations
English (EN) (43.72 KB - PDF)
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български (BG) (49.94 KB - PDF)
First published: 06/01/2021Last updated: 03/05/2022
español (ES) (42.62 KB - PDF)
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čeština (CS) (47.55 KB - PDF)
First published: 06/01/2021Last updated: 03/05/2022
dansk (DA) (45.96 KB - PDF)
First published: 06/01/2021Last updated: 03/05/2022
Deutsch (DE) (45.12 KB - PDF)
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eesti keel (ET) (40.46 KB - PDF)
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ελληνικά (EL) (46.61 KB - PDF)
First published: 06/01/2021Last updated: 03/05/2022
français (FR) (45.79 KB - PDF)
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hrvatski (HR) (44.48 KB - PDF)
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íslenska (IS) (44.54 KB - PDF)
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italiano (IT) (42.79 KB - PDF)
First published: 06/01/2021Last updated: 03/05/2022
latviešu valoda (LV) (46.72 KB - PDF)
First published: 06/01/2021Last updated: 03/05/2022
lietuvių kalba (LT) (45.48 KB - PDF)
First published: 06/01/2021Last updated: 03/05/2022
magyar (HU) (47.54 KB - PDF)
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Malti (MT) (46.49 KB - PDF)
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Nederlands (NL) (41.55 KB - PDF)
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norsk (NO) (45.42 KB - PDF)
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polski (PL) (48.55 KB - PDF)
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português (PT) (43.66 KB - PDF)
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română (RO) (45.04 KB - PDF)
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slovenčina (SK) (47.74 KB - PDF)
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slovenščina (SL) (42.28 KB - PDF)
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Product details
- Name of medicine
Leqvio
- Active substance
inclisiran
- International non-proprietary name (INN) or common name
inclisiran
- Therapeutic area (MeSH)
- Hypercholesterolemia
- Dyslipidemias
- Anatomical therapeutic chemical (ATC) code
C10AX
Pharmacotherapeutic group
Lipid modifying agents
Therapeutic indication
Leqvio 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.
Authorisation details
- EMA product number
EMEA/H/C/005333
Additional monitoring
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
- Marketing authorisation holder
Novartis Europharm Limited
Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland- Opinion adopted
15/10/2020
- Marketing authorisation issued
09/12/2020
- Revision
6
Assessment history
Leqvio : EPAR - Procedural steps taken and scientific information after the authorisation
English (EN) (184.32 KB - PDF)
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Leqvio : EPAR - Public assessment report
AdoptedReference Number: EMA/696912/2020
English (EN) (4.22 MB - PDF)
First published:
CHMP summary of positive opinion for Leqvio
AdoptedReference Number: EMA/CHMP/520993/2020
English (EN) (143.76 KB - PDF)
First published:
News on Leqvio
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020
More information on Leqvio
- EMEA-002214-PIP01-17-M01 - paediatric investigation plan
- Leqvio - direct healthcare professional communication (DHPC)
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