Leqvio
Authorised
This medicine is authorised for use in the European Union
inclisiran
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
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.
Product information
Latest procedure affecting product information:
IAIN/0030/G
25/11/2024
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 authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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 agentsTherapeutic 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.
News on Leqvio
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