Nilemdo
Authorised
This medicine is authorised for use in the European Union
bempedoic acid
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Nilemdo is a medicine for lowering levels of cholesterol in the blood. It contains the active substance bempedoic acid.
The medicine is used to reduce blood cholesterol levels in adults with primary hypercholesterolaemia or mixed dyslipidaemia (conditions that cause high levels of fats, including cholesterol, in the blood). Patients taking the medicine are required to be on a low-fat diet.
Nilemdo is used in combination with a statin, with or without other fat-lowering medicines (mainly ezetimibe). Nilemdo can also be used alone or in combination with other fat-lowering medicines without a statin in patients who cannot take statins, or without a statin but with ezetimibe.
For more information about using Nilemdo, see the package leaflet or contact your doctor or pharmacist.
Nilemdo blocks an enzyme in the liver called adenosine triphosphate citrate lyase, which is involved in making cholesterol. By blocking this enzyme, Nilemdo reduces blood levels of cholesterol, including low-density lipoprotein (LDL) cholesterol (known as ‘bad’ cholesterol), and other fatty substances made by the liver.
Primary hypercholesterolaemia or mixed dyslipidaemia
Nilemdo effectively reduced LDL cholesterol levels in four main studies involving adults with hypercholesterolaemia or mixed dyslipidaemia, in which Nilemdo was compared with placebo (a dummy treatment).
Two of the studies involved a total of 3,009 patients who were also taking the maximum tolerated doses of statins with or without other fat-lowering medicines. After three months, patients taking Nilemdo had reductions in LDL cholesterol levels of 15% in one study and 17% in the other, while there was a rise in LDL cholesterol levels of around 2% in patients taking placebo in both studies.
The other two studies involved a total of 614 patients who were not able to take a statin or were only taking a low dose. After three months, LDL cholesterol levels in these studies were reduced by 23% and 24% in patients taking Nilemdo compared with a decrease of 1% and an increase of 5% respectively in patients taking placebo.
Atherosclerotic cardiovascular disease
Nilemdo was studied in almost 14,000 adults who were intolerant to statins and who had or were at high risk for cardiovascular disease. After at least 2 years of treatment, 11.7% (819 out of 6,992) of patients given Nilemdo experienced a cardiovascular event (meaning death, heart attack, stroke, or surgery to restore blood flow to the heart), compared with 13.3% (927 out of 6,978) of patients given placebo.
For the full list of side effects and restrictions with Nilemdo, see the package leaflet.
The most common side effects with Nilemdo (which may affect up to 1 in 10 people) are hyperuricaemia (high blood levels of uric acid), pain in arms or legs, anaemia (low levels of red blood cells) and gout (painful inflammation in the joints caused by high blood levels of uric acid).
Nilemdo must not be used in pregnant or breastfeeding women. When Nilemdo is taken in combination with a statin called simvastatin, it can increase the risk of side effects of simvastatin. Therefore, Nilemdo must not be used with doses of simvastatin higher than 40 mg daily.
Nilemdo was shown to reduce levels of LDL cholesterol in adults with hypercholesterolaemia or mixed dyslipidaemia and lower the risk of major cardiovascular events in adults who have or are at high risk for cardiovascular disease. The safety profile of Nilemdo was considered acceptable. Nilemdo may increase the risk of side effects of statins and these should be managed appropriately. The European Medicines Agency therefore decided that Nilemdo’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 Nilemdo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Nilemdo are continuously monitored. Side effects reported with Nilemdo are carefully evaluated and any necessary action taken to protect patients.
Nilemdo received a marketing authorisation valid throughout the EU on 1 April 2020.
Product information
Latest procedure affecting product information:
R/0042
18/11/2024
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
- Nilemdo
- Active substance
- Bempedoic acid
- International non-proprietary name (INN) or common name
- bempedoic acid
- Therapeutic area (MeSH)
- Hypercholesterolemia
- Dyslipidemias
- Anatomical therapeutic chemical (ATC) code
- C10AX
Pharmacotherapeutic group
Lipid modifying agentsTherapeutic indication
Hypercholesterolaemia and mixed dyslipidaemia
Nilemdo 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 (see sections 4.2, 4.3, and 4.4) or,
• alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.
Cardiovascular disease
Nilemdo is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
• in patients on a maximum tolerated dose of a statin with or without ezetimibe or,
• alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.
For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
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