First new cholesterol-lowering oral treatments in over a decade, NILEMDO®▼ (bempedoic acid) and NUSTENDI®▼(bempedoic acid / ezetimibe), approved for use on the NHS

First new cholesterol-lowering oral treatments in over a decade, NILEMDO^®▼ (bempedoic acid) and NUSTENDI^®▼(bempedoic acid / ezetimibe), approved for use on the NHS

• High blood cholesterol increases the risk of cardiovascular disease, which causes over a quarter of all UK deaths. [i]^,[ii]
• NILEMDO^® (bempedoic acid) is a novel, first-in-class, oral treatment which lowers cholesterol, and can be combined with other oral treatments to help lower cholesterol even further.[iii]
• NUSTENDI^® (bempedoic acid / ezetimibe) is a novel oral treatment which combines two complementary ways of reducing cholesterol in a convenient once-daily tablet.[iv]

UXBRIDGE, UK, (18 March, 2021) – Daiichi Sankyo is pleased to announce that the National Institute for Health and Care Excellence (NICE) has today issued a Final Appraisal Document (FAD) recommending bempedoic acid and bempedoic acid / ezetimibe,^3,4 for treating primary hypercholesterolaemia or mixed dyslipidaemia (heterozygous familial and non-familial) as an adjunct to diet, only if statins are contraindicated or not tolerated, and ezetimibe alone does not control low-density lipoprotein cholesterol well enough, on the NHS in England.[v] This recommendation is an important milestone for patients who will have access to two important new treatment options for lowering LDL-C, a leading risk factor for cardiovascular events, such as heart attack or stroke.¹ Cardiovascular disease is one of the main causes of death and disability in the UK.¹

“Until now, patients with hypercholesterolaemia who cannot tolerate statins have had limited treatment options to effectively reduce their LDL-C levels, which is a leading modifiable risk factor of cardiovascular disease,” commented Professor Kausik Ray, Professor of Public Health and Honorary Consultant Cardiologist, Imperial College London. “Today’s announcement is fantastic news for patients as it marks the first new oral treatment options for high cholesterol to be made available in over a decade. Availability of treatments such as these is essential in tackling cardiovascular disease, the leading cause of death in the UK. When it comes to heart health and cholesterol, there is no such thing as ‘too low LDL-C’, highlighting the importance of treatments for high-risk patients.”

Jules Payne, Chief Executive at cholesterol charity HEART UK, said: “The impact of high LDL-C levels cannot be underestimated and account for one in four heart and circulatory disease deaths in the UK. High cholesterol is a silent killer and a condition that does not usually come with signs or symptoms, which is why we urge all adults to get a cholesterol check and know their numbers, regardless of age or how healthy they feel. Increasing access to cholesterol-lowering treatments such as these will make a tremendous difference to patients and help to tackle a significant risk factor in heart and circulatory diseases.”

Over seven million people in the UK are affected by cardiovascular disease and it is estimated that close to half of the adult population are living with cholesterol levels above national guidelines.² High cholesterol generally does not cause symptoms, meaning the only way to find out if you have it is by taking a blood test.[vi] The NHS has targeted preventing 150,000 cardiovascular events by 2028 as part of its Long Term Plan objectives.[vii]

Manuel Reiberg, Managing Director, Daiichi Sankyo UK said: “We are delighted that these innovative treatments will now be easily accessible to high-risk patients. We have a long-standing heritage in bringing cardiovascular therapies to the patients who need them and continue to be committed to investing in and supporting the unmet need in this disease area. Today’s decision is a landmark step forward for patients and the NHS in working towards a national ambition of preventing cardiovascular disease and events in line with the Long Term Plan. We are now more dedicated than ever to reduce the impacts of the UK’s biggest killer through our ongoing collaboration with the medical community and the NHS.”

[i] NHS. Cardiovascular Disease. Available at: https://www.nhs.uk/conditions/cardiovascular-disease/ Last accessed March 2021.

[ii] British Heart Foundation. UK factsheet. Available at: https://www.bhf.org.uk/-/media/files/research/heart-statistics/bhf-cvd-statistics-uk-factsheet.pdf?la=en Last accessed March 2021.

[iii] EMC. NILEMDO® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/11743/smpc Last accessed March 2021. 

[iv] EMC. NUSTENDI® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/11744/smpc Last accessed March 2021.

[v] National Institute for Health and Care Excellence. Bempedoic acid for treating primary hypercholesterolaemia or mixed dyslipidaemia [ID1515]. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta10534 Last accessed March 2021

[vi] British Heart Foundation. High Cholesterol – Causes, Symptoms & Treatments. Available at: https://www.bhf.org.uk/informationsupport/risk-factors/high-cholesterol. Last accessed March 2021.

[vii] NHS. The NHS Long Term Plan. Available at: https://www.longtermplan.nhs.uk/wp-content/uploads/2019/08/nhs-long-term-plan-version-1.2.pdf. Last accessed March 2021.