Overview

Nustendi is a medicine for lowering levels of cholesterol in the blood.

It is used in patients 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.

Nustendi contains the active substances bempedoic acid and ezetimibe.

Nustendi is used in combination with a statin in patients whose cholesterol levels are not lowered enough by the maximum dose of a statin taken together with ezetimibe. Nustendi can also be used alone in patients who cannot take statins and whose cholesterol levels are not lowered enough by ezetimibe. The medicine can be used to replace separate tablets of bempedoic acid and ezetimibe in patients already taking them.

Nustendi can only be obtained with a prescription and is available as tablets (180 mg bempedoic acid / 10 mg ezetimibe). The recommended dose of Nustendi is one tablet a day.

For more information about using Nustendi, see the package leaflet or contact your doctor or pharmacist.

The active substances in Nustendi, bempedoic acid and ezetimibe, work in different ways to lower blood cholesterol.

Bempedoic acid works by blocking an enzyme in the liver called adenosine triphosphate citrate lyase, which is involved in making cholesterol. This leads to a reduction of the level of low-density lipoprotein (LDL) cholesterol, known as ‘bad’ cholesterol, in the blood and also reduces other fatty substances made by the liver.

Ezetimibe works by binding to a gut protein called ‘Niemann-Pick C1 Like 1’, preventing cholesterol from being absorbed into the blood from the gut.

Two studies showed that bempedoic acid and ezetimibe (the active substances of Nustendi) effectively reduced LDL cholesterol levels in patients with hypercholesterolaemia and heart disease or who were at high risk of heart disease. High cholesterol is a risk factor for heart disease.

The first study involved 382 patients also taking the maximum tolerated doses of statins. After three months, LDL cholesterol levels were reduced by 36% in patients taking bempedoic acid and ezetimibe compared with a reduction of 23% with ezetimibe alone, 17% with bempedoic acid alone and an increase of around 2% with placebo (a dummy treatment).

The second study involved 269 patients with high cholesterol levels who were not able to take a statin or were taking a low dose of a statin. All the patients were also taking ezetimibe. After three months, LDL cholesterol levels were reduced by 23% in patients taking bempedoic acid in addition to ezetimibe compared with an increase of around 5% in patients taking placebo and ezetimibe.

The most common side effects with Nustendi (which may affect around 1 in 20 people) are hyperuricaemia (high blood levels of uric acid) and constipation.

Nustendi must not be used in pregnant or breast-feeding women. When Nustendi is taken in combination with a statin called simvastatin it can increase the risk of side effects of simvastatin, therefore the dose of simvastatin must not be higher than 40 mg daily. Nustendi must not be taken with a statin in patients with active liver disease or with unexplained high levels of serum transaminases (blood test results that could indicate liver problems).

For the full list of side effects and restrictions with Nustendi, see the package leaflet.

Nustendi was shown to reduce levels of LDL cholesterol and so is expected to help reduce the risk of heart disease. The safety profile of Nustendi was considered acceptable. Nustendi may increase the risk of side effects of statins and these should be managed appropriately. The European Medicines Agency therefore decided that Nustendi’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 Nustendi have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Nustendi are continuously monitored. Side effects reported with Nustendi are carefully evaluated and any necessary action taken to protect patients.

Nustendi received a marketing authorisation valid throughout the EU on 27 March 2020.

Nustendi : EPAR - Medicine overview

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Nustendi : EPAR - Risk-management-plan summary

Product information

Nustendi : EPAR - Product information

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Latest procedure affecting product information: IB/0026

19/04/2022

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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).

Nustendi : EPAR - All authorised presentations

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Product details

Name of medicine
Nustendi
Active substance
  • Bempedoic acid
  • Ezetimibe
International non-proprietary name (INN) or common name
  • bempedoic acid
  • ezetimibe
Therapeutic area (MeSH)
  • Hypercholesterolemia
  • Dyslipidemias
Anatomical therapeutic chemical (ATC) code
C10B

Pharmacotherapeutic group

Lipid modifying agents

Therapeutic indication

Nustendi 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 in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe
  • alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,
  • in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin

Authorisation details

EMA product number
EMEA/H/C/004959

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
Daiichi Sankyo Europe GmbH

Zielstattstrasse 48
81379 Munich
Germany

Opinion adopted
30/01/2020
Marketing authorisation issued
27/03/2020
Revision
5

Assessment history

Nustendi : EPAR - Procedural steps taken and scientific information after authorisation

Nustendi : EPAR - Public assessment report

CHMP summary of positive opinion for Nustendi

Topics

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