-ENDS-
About MILOS
MILOS (NCT04579367) is an ongoing, multinational, European observational study in adult patients diagnosed with primary hypercholesterolaemia or mixed dyslipidaemia. The aim is to evaluate the real-world use of bempedoic acid and bempedoic plus ezetimibe FDC. Patients in the German cohort were recruited from 125 sites between January 2021 and January 2022 and were followed up for 2 years after baseline measurements.1 Change in LDL-C levels and the proportion of patients achieving LDL-C goal were assessed in patients at pre-treatment, 1Y and 2Y visits. Analyses were stratified by investigator-assessed CV risk, based on the ESC/EAS dyslipidaemia guidelines.1 Beyond Germany, MILOS has sites in Austria, Belgium, Italy, the Netherlands, Spain, Switzerland and the UK.9
About Bempedoic Acid and its Fixed-Dose Combination with Ezetimibe
Bempedoic acid (NILEMDO®) is a first-in-class, oral, once-daily treatment to lower cholesterol, and can be combined with other oral treatments to help lower cholesterol even further.10
Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver.10 Bempedoic acid acts on the well-known cholesterol synthesis pathway, upstream of the statin target in the liver, which allows additional LDL-C lowering when added to statin or other LDL-C-lowering therapies.11 Bempedoic acid is not activated in skeletal muscle.10
Bempedoic acid is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet:10
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,10
alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.10
Bempedoic acid is indicated in adults with established or at high risk for atherosclerotic CV disease to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:10
in patients on a maximum tolerated dose of statin with or without ezetimibe or,10
alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin in contraindicated.10
The bempedoic acid / ezetimibe FDC (NUSTENDI®) combines two complementary ways of reducing cholesterol in a once-daily tablet.
Bempedoic acid / ezetimibe FDC is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet:12
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,12
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,12
in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.12
Bempedoic acid / ezetimibe FDC is indicated in adults with established or at high risk for atherosclerotic CV disease to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:12
in patients on a maximum tolerated dose of statin and not adequately controlled with additional ezetimibe treatment or,12
in patients who are either statin-intolerant, or for whom a statin in contraindicated, and not adequately controlled with ezetimibe treatment or,12
in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.12
Daiichi Sankyo Europe has licensed exclusive commercialisation rights to bempedoic acid and its FDC with ezetimibe (marketed as NILEMDO® and NUSTENDI®) in the European Economic Area, UK, Turkey and Switzerland from Esperion and is the full Marketing Authorisation Holder in these territories.
About Daiichi Sankyo
Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical need.
For more information, please visit https://www.daiichi-sankyo.eu/
▼ This medicinal product is subject to additional monitoring.
HQ/BIL/09/24/0001
View source version on businesswire.com: https://www.businesswire.com/news/home/20240926678909/en/
Gillian D’Souza
Daiichi Sankyo Europe GmbH
Senior Manager, Public Relations, Specialty Medicines
+49 1515 5195599
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Publish date : 2024-09-27 01:58:00
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