Pooled analyses show NILEMDO ® ▼ significantly lowers cholesterol in different subgroups in Phase 3 data presented at AHA 2020

Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced results from two pooled analyses from four Phase 3 clinical trials for bempedoic acid. The data were presented at the virtual American Heart Association (AHA) Scientific Sessions 2020.

One pooled analysis including 3,621 patients explored low-density lipoprotein cholesterol (LDL-C) reduction in male participants compared to female participants across two pools of patients; an on-statins pool and a statin-intolerant pool.^**3 Results showed that bempedoic acid significantly lowered LDL-C at Week 12 in both sexes compared with placebo.³ In the on-statins pool bempedoic acid significantly reduced LDL-C by 21.2% in female participants vs. 17.4% in male participants (placebo-corrected; interaction p value = 0.044). In the statin-intolerant pool LDL-C was reduced by 27.7% in female participants vs. 22.1% in male participants (placebo-corrected; interaction p value = 0.079), which was not statistically significant.³ Baseline levels of LDL-C were slightly higher in female participants.³ Bempedoic acid was generally well tolerated by both sexes in both pools.³

In Europe, cardiovascular disease causes a greater proportion of deaths among women (51%) than men (42%) overall, killing twice as many women as all forms of cancer combined.⁴ Evidence shows that women have often been underrepresented in clinical trials of lipid-lowering therapies and cardiovascular outcomes, and analyses of trial data by sex are deficient in cardiovascular research.^4,5

“These data demonstrate the benefits of bempedoic acid in both women and men who struggle to keep their LDL-C levels low, many of whom are already taking other lipid-lowering therapies to try and reach their recommended LDL-C levels,” said Anne C Goldberg, Professor of Medicine, Washington University School of Medicine, USA. “As women have been historically underrepresented in clinical trials, and we know that both sexes are affected differently by disease, these results presented today are important in analysing the sexes separately and understanding the impact of treatment on both groups.”

“It is important for the future of patient care that we examine bempedoic acid data across multiple subgroups to help identify different patients that may benefit from this treatment. These data further add to the robust evidence behind bempedoic acid as an option that can be added on to existing lipid-lowering therapies to further reduce LDL-C levels, helping patients take back control of their cholesterol,” said Wolfgang Zierhut MD, Head Antithrombotic and Cardiovascular Therapeutic Area at Daiichi Sankyo Europe. “With up to 80% of patients not reaching guideline-recommended LDL-C goals despite receiving treatments such as statins and other lipid-lowering therapies, we are committed to continuing to help provide solutions to support these patients.”

The second pooled analysis presented at AHA 2020 assessed the efficacy and safety of bempedoic acid in patients from four Phase 3 clinical trials who were unable to tolerate statins.⁶ Results showed that bempedoic acid significantly reduced LDL-C by an average of –26.5% (95% CI: –29.7, –23.2) vs. placebo in patients unable to use statins. Bempedoic acid was shown to be generally well-tolerated in patients with hypercholesterolaemia unable to tolerate a statin.⁶

*Note: Daiichi Sankyo Europe strives to be inclusive in our language. In this press release, we follow the recommendation for reporting of demographic data in research articles of the language guidance outlined in “Reporting Sex, Gender, or Both in Clinical Research?” from The Journal of the American Medicine Association (JAMA). November 8, 2016 Volume 316, Number 18

**Note: the on-statins pool were patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) who were receiving background lipid-lowering therapy, including maximally tolerated statins. The statin-intolerant pool were patients with a history of problems taking statins and included patients who were taking no statins or no more than the lowest approved starting dose of a statin.

– ENDS –

About NILEMDO^®

NILEMDO^® (bempedoic acid) is a new, first-in-class, oral, once-daily treatment which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further.¹ NILEMDO^® inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver.¹

NILEMDO^® has been approved for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet¹

• 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.

NILEMDO^® 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 lipid-lowering therapies.¹ Due to its unique mechanism of action, NILEMDO^® is not activated in skeletal muscle which decreases the potential for muscle-related side effects.^1,2

About NUSTENDI^®

NUSTENDI^® is a new oral treatment which combines two complementary ways of reducing cholesterol in a convenient once-daily tablet. NUSTENDI^® is a fixed dose combination tablet containing bempedoic acid (the active pharmaceutical ingredient in NILEMDO^®) and ezetimibe.⁷

NUSTENDI^® has been approved for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:⁷

• 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 a statin.

Daiichi Sankyo Europe has licensed exclusive commercialisation rights to NILEMDO^® and NUSTENDI^® in the European Economic Area, Turkey and Switzerland from Esperion and is the full Marketing Authorisation Holder in these territories.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centred around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.

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¹ European Medicines Agency. NILEMDO^® Summary of Product Characteristics. March 2020.
² Pinkosky SL, et al. Liver- specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nature Communications. 2016; 7:13457. DOI:10.1038/ncomms13457.
³ Goldberg AC, et al. Efficacy and safety of bempedoic acid by sex: pooled analyses from phase 3 trials. Poster presentation at American Heart Association Scientific Sessions. November 2020, Abstract P742.
⁴ Tamargo J, et al. Gender differences in the effects of cardiovascular drugs. Eur Heart J CardiovascPharmacother. 2017; 3:163-182.
⁵ Cholesterol Treatment Trialists' (CTT) Collaboration, et al. Efficacy and safety of LDL-lowering therapy among men and women: meta-analysis of individual data from 174,000 participants in 27 randomised trials. Lancet. 2015; 385:1397-1405.
⁶ Laufs U, et al. Efficacy and safety of bempedoic acid in patients who cannot tolerate any dose of a statin: pooled analyses from phase 3 clinical trials. Poster presentation at American Heart Association Scientific Sessions. November 2020, Abstract P2139.
⁷ European Medicines Agency. NUSTENDI^® Summary of Product Characteristics. March 2020.

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Contact information

Dr. Wolfgang Schiessl (Europe)
Daiichi Sankyo Europe GmbH
Director Product PR and Communications, Cardiovascular Europe
+49 151 1714 7317