Statin intolerance occurs in up to 15-20% of treated patients. The combined use of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors with ezetimibe is commonly performed in these patients, and has been associated with an estimated LDL-C reduction of 65-70%. This drug combination may be insufficient to reach the LDL-C target in high- and very-high-risk patients with statin intolerance, also considering the goals recommended by the current international guidelines. Also, PCSK9 inhibitor dosage escalations frequently fail to achieve the target. Doubling the dosage of alirocumab from 75 mg to 150 mg, when administrated as monotherapy, determines a further reduction of only 3,6% of LDL-C serum level. The full dose of Evolocumab (420 mg every two weeks), was approved only in the setting of homozygous familiar hypercholesterolemia.
Bempedoic acid is an oral, once-daily prodrug, metabolized in the liver to an active inhibitor of ATP-citrate lyase, blocking cholesterol synthesis upstream of 3-hydroxy-3-methylglutaryl-coenzyme A reductase and thereby increasing hepatic expression of the LDL receptor and decreasing circulating LDL-C levels.
The CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen) Harmony trial demonstrated that bempedoic acid in addition to maximally tolerated statin therapy did not lead to a higher incidence of adverse events compared to placebo and significantly lowered LDL-C levels. In the CLEAR Serenity study, bempedoic acid showed a safe and effective profile compared with placebo in patients with statin intolerance. In the CLEAR Tranquility, it provided an oral therapeutic option complementary to ezetimibe in patients intolerant to high-dose statins who required additional LDL-C lowering.
The synergistic effect of bempedoic acid plus PCSK9 inhibitors has been investigated by one phase 2 trial (NCT03193047), which showed a statistical superiority of bempedoic acid plus evolocumab strategy versus placebo plus evolocumab in terms of percent change in LDL-C up to 2 months. To date, no randomized phase 3 clinical trial have evaluated the effect of bempedoic acid in association with anti-PCSK9 and ezetimibe in statin-intolerant patients not attaining the recommended LDL-C target.
The investigators hypothesized that the association of bempedoic acid with PCSK9 inhibitors and ezetimibe may be safe and effective in reducing LDL-C in statin-intolerant patients.

开始日期2024-05-01

申办/合作机构

University of Salerno

100 项与贝派地酸相关的临床结果

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100 项与贝派地酸相关的转化医学

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100 项与贝派地酸相关的专利（医药）

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项与贝派地酸相关的文献（医药）

2024-10-01·Cell Metabolism

Bempedoic acid suppresses diet-induced hepatic steatosis independently of ATP-citrate lyase

Article

作者: Murali, Nivitha ; Metallo, Christian M. ; Supplee, Julianna G. ; Welles, Jaclyn E ; Pinheiro, Laura V. ; Kuna, Ramya S. ; Farria, Aimee T. ; Kumar, Avi ; Supplee, Julianna G ; Drummond, Jack M. ; Wellen, Kathryn E. ; Liu, Joyce Y ; Kantner, Daniel S. ; Demetriadou, Christina ; Sharma, Prateek ; Drummond, Jack M ; Zhao, Steven ; Titchenell, Paul M ; Pinheiro, Laura V ; Farria, Aimee T ; Nguyen, Phuong T.T. ; Liu, Joyce Y. ; Titchenell, Paul M. ; Kantner, Daniel S ; Chatoff, Adam ; Snyder, Nathaniel W ; Ruchhoeft, Mauren L. ; Kuna, Ramya S ; Shiue, Mia ; Welles, Jaclyn E. ; Ruchhoeft, Mauren L ; Snyder, Nathaniel W. ; Wellen, Kathryn E ; Metallo, Christian M ; Megill, Emily ; Sharma, Prateek V ; Nguyen, Phuong T T

ATP citrate lyase (ACLY) synthesizes acetyl-CoA for de novo lipogenesis (DNL), which is elevated in metabolic dysfunction-associated steatotic liver disease. Hepatic ACLY is inhibited by the LDL-cholesterol-lowering drug bempedoic acid (BPA), which also improves steatosis in mice. While BPA potently suppresses hepatic DNL and increases fat catabolism, it is unclear if ACLY is its primary molecular target in reducing liver triglyceride. We show that on a Western diet, loss of hepatic ACLY alone or together with the acetyl-CoA synthetase ACSS2 unexpectedly exacerbates steatosis, linked to reduced PPARα target gene expression and fatty acid oxidation. Importantly, BPA treatment ameliorates Western diet-mediated triacylglyceride accumulation in both WT and liver ACLY knockout mice, indicating that its primary effects on hepatic steatosis are ACLY independent. Together, these data indicate that hepatic ACLY plays an unexpected role in restraining diet-dependent lipid accumulation and that BPA exerts substantial effects on hepatic lipid metabolism independently of ACLY.

2024-10-01·INTERNATIONAL JOURNAL OF CARDIOLOGY

Safety evaluation of bempedoic acid: A pharmacovigilance analysis using FDA adverse event reporting system data

Article

作者: Wei, Qucheng ; Chen, Yuwen ; Zhang, Jin ; Huang, Anan ; Li, Bing

BACKGROUND:

Bempedoic acid exhibits promising potential in hyperlipidemia therapy and preventing cardiovascular events. However, investigations into its adverse drug reactions remain scant. This study seeks to utilize data mining techniques with the FDA Adverse Event Reporting System (FAERS) database to assess adverse drug events (ADEs) linked to bempedoic acid.

METHODS:

Based on the drug's market release timeline, we extracted data from the FAERS database covering the fourth quarter of 2020 through the fourth quarter of 2023 for disproportionality analysis.

RESULTS:

This study gathered a total of 5,797,543 adverse event case reports, of which 735 were linked to bempedoic acid. These reports covered 19 System Organ Classes (SOCs) and 22 Preferred Terms (PTs). Predominantly, the musculoskeletal and nervous systems were implicated in these adverse events. By conducting PT-level screening, various signals for ADEs were detected, including myalgia (ROR 30.33, PRR 28.51, IC 4.83, EBGM 28.47), arthralgia (n = 34, ROR 6.34, PRR 6.09, IC 2.61, EBGM 6.09), tendon disorders (ROR 99.57, PRR 98.75, IC 6.62, EBGM 98.28), and dizziness (ROR 3.18, PRR 3.13, IC 1.65, EBGM 3.13). Particularly noteworthy was the hypertensive crisis (ROR 28.63, PRR 28.51, IC 4.83, EBGM 28.47), which exhibited a robust signal strength, an observation previously unreported in clinical studies and drug labeling.

CONCLUSION:

While our results are largely consistent with the drug's specifications, several new adverse reaction signals, such as hypertensive crisis, have not been previously documented. Therefore, further investigations are necessary to assess these unlabeled adverse reactions, offering crucial support for the clinical utilization of bempedoic acid.

2024-09-22·Cureus Journal of Medical Science

A Comparative Analysis of Low-Density Lipoprotein Cholesterol (LDL-C)-Lowering Activities of Bempedoic Acid, Inclisiran, and PCSK9 Inhibitors: A Systematic Review

Review

作者: Eerike, Madhavi ; Rajendran, Yazhini ; Kondampati, Nikhila ; Nandhakumar, Madhumita ; Nagireddy, Uma Maheswari ; Konda, Venu Gopala R ; Chalissery, Leo F ; Mali, Kalpana

Newer drugs, such as bempedoic acid, inclisiran, alirocumab, and evolocumab have recently been introduced for dyslipidemia. This systematic review aims to perform a comparative analysis of these drugs' low-density lipoprotein cholesterol (LDL-C)-lowering activities. The PubMed database was utilized to search for randomized controlled trials. Articles were screened and selected based on specific inclusion and exclusion criteria. The primary outcome of this review is to compare the percentage reduction of LDL-C and apolipoprotein-B, along with the number of reported serious adverse events (SAEs) in trials specific to each drug. A total of 14 studies were included, four for bempedoic acid and alirocumab and three for evolocumab and inclisiran. The maximum percentage reduction in LDL-C and apolipoprotein-B from baseline to 12 weeks was observed with alirocumab, administered at 150 mg subcutaneously twice weekly for 12 weeks, achieving reductions of 72.4% and 57.9%, respectively. Lesser reductions were observed with bempedoic acid, administered at 180 mg once daily orally for 12 weeks. The highest number of SAEs were reported with bempedoic acid (216, 10%) and inclisiran (181, 11%; 175, 11%). This systematic review showed that alirocumab achieved the greatest reductions in LDL-C and apolipoprotein-B and a better safety profile. Newer LDL-C-lowering drugs show promise in improving lipid profiles, patient compliance, and safety. However, these findings are not conclusive, as other factors also influence treatment choice.

项与贝派地酸相关的新闻（医药）

2024-09-27

·Business Wire

Final Real-World Results from MILOS German Cohort Demonstrate Strong Increase in LDL-C Goal Achievement With Addition of Bempedoic Acid

MUNICH--( BUSINESS WIRE )--For EU media only Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today announced final 2-year follow-up data from the German cohort of the multinational, European observational MILOS study. 1 The study evaluated the real-world use of bempedoic acid, marketed as NILEMDO ® ▼ and its FDC with ezetimibe, NUSTENDI ® ▼, in patients with primary hypercholesterolaemia or mixed dyslipidaemia. The results, presented in Hamburg, Germany at DGK Hertztage 2024, demonstrated the effectiveness and safety profile of bempedoic acid, both alone and in combination with other lipid-lowering therapies (LLTs) in clinical practice. 1 Raised LDL-C is a key modifiable contributor to risk of major cardiovascular events, with studies showing that every 1 mmol/L reduction in LDL-C is associated with a 22% reduction in major cardiovascular events after one year. 5,6 The German cohort of MILOS study comprising 973 patients from 125 sites in Germany, is one of the most comprehensive assessments of bempedoic acid in a real-world clinical setting to-date in Germany. 1 Patients were followed-up for two years, with LDL-C levels assessed at pre-treatment, one year (1Y) and two years (2Y). Overall, 638 of 973 patients (65.6%) completed 2Y follow up, with LDL-C values at pre-treatment, 1Y and 2Y available for 451 patients. In these 451 patients, a mean reduction of LDL-C levels from 3.1 mmol/L (121.4 mg/dL) at pre-treatment, to 2.0 mmol/L (77.2 mg/dL) was observed, representing an average relative reduction of 30.3% in the overall population. 1 Additionally, the percentage of patients reaching their LDL-C goals increased from 4.9% at pre-treatment to 35.3% at the 2Y follow-up – an approximately 7-fold increase. 1 The proportions of high-risk and very high-risk patients reaching LDL-C goals increased from 5.6% to 32.5%, and 3.6% to 35.2%, respectively. 1 Overall, more than 80% of patients received bempedoic acid in combination with other LLTs at pre-treatment and 2Y, including statins and ezetimibe. The safety profile of bempedoic acid in this real-world population was assessed at 1Y and 2Y and was consistent with that observed in the CLEAR clinical trial programme. 2,3,4 “By significantly lowering LDL-C levels toward guideline goals, we are taking a vital step in reducing the risk of cardiovascular events, which can have a profound impact on a person’s long-term health and quality of life,” said Professor Ioanna Gouni-Berthold, University of Cologne, Center for Endocrinology, Diabetes, and Preventive Medicine and Executive Board Member of the International Atherosclerosis Society . “Cardiovascular disease remains Europe’s leading cause of death, yet the majority of premature CV events are preventable,” 7,8 said Dr. Stefan Seyfried, Vice President Medical Affairs, Specialty Medicines, at Daiichi Sankyo Europe GmbH . “ The findings from this cohort reinforce the benefit provided by bempedoic acid for reducing LDL-C levels. Our long-term goal is to empower the medical community with real-world insights to improve CVD prevention and, ultimately, improve patient care.” -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. References 1 DGK Hertztage 2024 Abstract. Real-world effectiveness and safety of bempedoic acid in Europe: final 2-year results from the MILOS German cohort. Gouni-Berthold, I et al. 2 Nissen SE, et al. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med . 2023;388:1353–64 3 Ray KK, et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med . 2019; 380:1022–32 4 Ballantyne CM, et al . Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol . 2020; 27(6): 593–603 5 Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170 000 participants in 26 randomised trials. Lancet. 2010. 376(9753): 1670–1681 6 NHS England. Improving lipid management to reduce cardiovascular disease and save lives. Available at: https://www.england.nhs.uk/long-read/improving-lipid-management-to-reduce-cardiovascular-disease-and-save-lives/#:~:text=Raised%20LDL%20cholesterol%20is%20one,vascular%20events%20after%201%20year . Last accessed September 2024. 7 Eurostat. (2023) Causes of death statistics. Available at: https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Causes_of_death_statistics#Major_causes_of_death_in_the_EU_in_2020 . Last accessed September 2024. 8 World Heart Federation. Prevention. Available at: https://world-heart-federation.org/what-we-do/prevention/#:~:text=An%20estimated%2080%25%20of%20cardiovascular,and%20“knowing%20your%20numbers ”. Last accessed September 2024 9 ClinicalTrials.gov. Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia (MILOS). Available at: https://clinicaltrials.gov/study/NCT04579367#contacts-and-locations . Last accessed September 2024. 10 European Medicines Agency. Nilemdo – Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf . Last accessed September 2024. 11 Pinkosky, S.L., et al . Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun . 2016. 7: 13457. 12 European Medicines Agency. Nustendi –Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/nustendi-epar-product-information_en.pdf . Last accessed September 2024 HQ/BIL/09/24/0001

上市批准临床结果AHA会议临床研究引进/卖出

2024-09-03

·FiercePharma

Daiichi study finds gender inequality in European cardiovascular care

Daiichi Sankyo sells Esperion Therapeutics’ lipid-lowering drugs Nilemdo and Nustendi in Europe. Daiichi Sankyo has identified inequalities in cardiovascular disease treatment and outcomes, finding that women in Europe are less likely than men to receive lipid-lowering therapies and achieve LDL cholesterol goals.The findings come from a subanalysis of SANTORINI, an observational study Daiichi funded to shed light on the care of people with high and very high cardiovascular risk in Europe. Investigators looked at how physicians assess risk and approach lipid-lowering regimens as well as the extent to which their decisions would enable the attainment of lipid goals set by cardiology groups.Daiichi used the European Society of Cardiology Congress in London to share more data from the SANTORINI study. The subanalysis looked at 5,197 men and 2,013 women with similar mean ages, 65 years and 66 years, respectively. Daiichi said guideline recommendations for the men and women are similar.At baseline, physicians opted against prescribing a lipid-lowering therapy to 23.9% of women, compared to 20.7% of men. Most of the untreated women had received a lipid-lowering drug one year later, but the gap with men persisted. The proportion of women not on lipid-lowering therapy after one year was 3.9%. The figure for men was 2.7%. Women were less likely to achieve cholesterol targets. The proportion of patients reaching LDL-C goals improved from baseline to one-year follow-up in both cohorts but was greater in men, 22.9% and 33.3%, respectively, than in women. The figures for women were 16.9% and 24.6%.“This new sub-analysis of the SANTORINI study further suggests that in clinical practice, women as a group were being disproportionally undertreated and do not always reach recommended LDL-C level goals,” the University of Lausanne’s David Nanchen, M.D., said in a statement. “These findings underscore the need for more widespread attention to better manage the risk of cardiovascular disease in women.”Daiichi, which sells Esperion Therapeutics’ lipid-lowering drugs Nilemdo and Nustendi in Europe, said its commitment to addressing key unmet needs and barriers in cardiovascular care is reinforced after seeing the data. Nilemdo and Nustendi were approved to reduce the risk of adverse cardiovascular events in Europe in May. Daiichi named the drugs as growth drivers at its EU specialty unit in its first quarter.

上市批准AHA会议

2024-08-27

·研发客

里程碑付款，我们能拿到多少？| 行业观察

// • 过去9年，超过6成的里程碑无法达成。 • 越到药物研发后期，里程碑实现难度越大。 • 里程碑付款可能由于买方拖延进度或触发支付条款界定不明确引起纠纷。根据美国市场调研公司SRS ACQUIOM去年9月发布的报告，在过去9年生物制药领域的BD交易中，60%以上的里程碑无法达成。截止到报告发布时，2023年里程碑达成率仅为22%。越往后里程碑实现难度越大在生物医药领域，BD交易很多时候需要被许可方达成一定条件的里程碑，许可方才能收到对应的付款，即“或有对价”支付安排（Earn-out），从而对冲最终产品研发或上市失败的风险。在这份报告中，从2008～2023年年中，SRS ACQUIOM统计了生物医药领域发生的163笔交易，其中设置Earn-out条款的交易比例高达86%。那么，那些令人惊叹的交易巨额中，最终又有多少能实打实进入许可方口袋呢？从交易数量来看，2015～2021年生物制药领域的BD交易里程碑达成率在27%～34%之间，这一数据在2023年更是骤然降至22%。这也意味着，过去9年该领域60%以上的里程碑无法达成，最高达到78%。 2015~2023年里程碑事件达成率数据来源｜SRS ACQUIOM 报告还显示，较大金额的里程碑付款主要集中在药物开发的后期阶段，不过越到后期里程碑实现难度也越大。例如，在2023年年中到期的里程碑事件中，3期临床阶段对应触发的里程碑金额超过了100亿美元，但实际已支付的金额只有11亿美元，占比11%；商业化阶段对应触发的里程碑金额也高达75亿美元，但实际支付的金额仅3%，也就是说只有2亿美元左右。生物制药领域2023年年中到期的各研发阶段里程碑事件达成情况统计数据来源｜SRS ACQUIOM 诉讼焦点在哪在交易项目推进过程中，常常会发生临床研究失败，或者被许可方由于战略调整等原因终止协议的情况，使得里程碑金额最终未能支付。与此同时，里程碑环节常见的履约纠纷也影响了实际支付。据SRS ACQUIOM的数据，在共计211笔于2023年年中之前存在里程碑事件及对应付款安排的生物医药交易中，28%的交易产生了争议，其中44%的争议未能得到协商解决，最终触发了诉讼仲裁的程序。存在“里程碑”事件的交易争议情况统计数据来源｜SRS ACQUIOM 结合既往的一些案例来看，争议的主要原因包括许可方认为被许可方故意拖延进度，或合作协议中对达成里程碑的条件界定不够明确。比如今年7月，许可方Admune Therapeutics的代表公司Aramis就起诉了诺华，称其故意拖延此前收购的一款IL-15激动剂的开发进度，导致许可方损失了9.4亿美元的里程碑付款以及额外的赔偿费用。据Endpoints报道，这项交易发生在2015年，当时该许可产品处在1期临床研究阶段。此后几年，该产品并未迎来太多进展。2021年6月，诺华宣布将停止已进行数年的1期临床招募。今年2月，诺华表示将不再继续研究该候选药物，并希望重新转让其权利。 Aramis称，诺华在与ImmunityBio公司就IL-15潜在专利侵权问题进行对话时出现了失误。ImmunityBio的IL-15受体激动剂Anktiva已于今年4月在美国获批上市。类似的戏码也在BMS与Celgene之间上演。 2019年BMS收购Celgene，依据交易中的或有价值权 (CVR) 协议约定，如果BMS交割后在规定时间内（2020年12月31日之前），完成三种新药在美国获批，则需向Celgene额外支付64亿美元。后来由于其中一款药物CAR-T细胞疗法Breyanzi晚了一个多月才获得FDA批准，Celgene与64亿美元失之交臂。随后，Celgene原股东的受托人UMB Bank NA向法院提起诉讼，指出BMS违反了CVR协议，未能“尽最大努力”让相关药物按时获得批准，具体包括未能及时向FDA提交有关的关键信息，未能采取必要措施准备好生产设施以配合FDA检查。目前诉讼还在进行中。另一项Esperion和第一三共之间的诉讼，则是因为双方对协议条款中触发里程碑付款的3期试验终点的界定存在分歧，第一三共拒绝支付3亿美元的里程碑付款。在诉讼结果一直悬而未决的情况下，双方于今年年初达成一项新的协议，第一三共将向Esperion支付1.25亿美元，以解决此前的纠纷，并制定相关产品Nilemdo和Nustendi在欧洲和其他地区的合作计划。编辑 | 陈小娟 Xiaojuan.chen@PharmaDJ.com 总第2188期访问研发客网站，深度报道和每日新闻抢鲜看 www.PharmaDJ.com

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100 项与贝派地酸相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D10691	贝派地酸	C10AX15	DB11936

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
心血管疾病	美国	Esperion Therapeutics, Inc.	2024-03-22
心肌梗塞	美国	Esperion Therapeutics, Inc.	2024-03-22
原发性高脂血症	美国	Esperion Therapeutics, Inc.	2024-03-22
血脂障碍	欧盟	Daiichi Sankyo Europe GmbH	2020-04-01
血脂障碍	冰岛	Daiichi Sankyo Europe GmbH	2020-04-01
血脂障碍	列支敦士登	Daiichi Sankyo Europe GmbH	2020-04-01
血脂障碍	挪威	Daiichi Sankyo Europe GmbH	2020-04-01
原发性高胆固醇血症	欧盟	Daiichi Sankyo Europe GmbH	2020-04-01
原发性高胆固醇血症	冰岛	Daiichi Sankyo Europe GmbH	2020-04-01
原发性高胆固醇血症	列支敦士登	Daiichi Sankyo Europe GmbH	2020-04-01
原发性高胆固醇血症	挪威	Daiichi Sankyo Europe GmbH	2020-04-01
动脉粥样硬化	美国	Esperion Therapeutics, Inc.	2020-02-21
杂合子家族性高胆固醇血症	美国	Esperion Therapeutics, Inc.	2020-02-21

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适应症	最高研发状态	国家/地区	公司	日期
高低密度脂蛋白胆固醇血症	临床3期	日本	Otsuka Pharmaceutical Co., Ltd.	2023-02-13
高脂血症	临床3期	美国	Esperion Therapeutics, Inc.	2017-10-23
高胆固醇血症	临床3期	美国	Esperion Therapeutics, Inc.	2016-01-21
高胆固醇血症	临床3期	加拿大	Esperion Therapeutics, Inc.	2016-01-21
高胆固醇血症	临床3期	德国	Esperion Therapeutics, Inc.	2016-01-21
高胆固醇血症	临床3期	荷兰	Esperion Therapeutics, Inc.	2016-01-21
高胆固醇血症	临床3期	波兰	Esperion Therapeutics, Inc.	2016-01-21
高胆固醇血症	临床3期	英国	Esperion Therapeutics, Inc.	2016-01-21
高血压	临床2期	美国	Esperion Therapeutics, Inc.	2014-06-16
2型糖尿病	临床2期	美国	Esperion Therapeutics, Inc.	2012-04-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05683340 (Company_Website) 人工标引	临床3期	高胆固醇血症	96	Bempedoic acid 180 mg	鏇糧壓壓網鏇憲鹹窪願(網鹹築積淵夢襯觸顧壓) = 獵餘簾顧膚淵願鑰夢範廠積醖廠獵鏇衊衊夢醖 (鏇蓋衊餘遞築鑰衊窪糧 ) 达到	积极	2024-05-20
				Placebo	鏇糧壓壓網鏇憲鹹窪願(網鹹築積淵夢襯觸顧壓) = 遞醖鹹衊鏇餘鏇壓獵範廠積醖廠獵鏇衊衊夢醖 (鏇蓋衊餘遞築鑰衊窪糧 ) 达到
NCT04784442 (CTgov)	临床2期	高胆固醇血症	188	Placebo	範壓繭繭壓糧積積廠壓(選齋艱鏇鏇蓋繭壓鏇觸) = 網蓋鹽顧鹹衊選艱範遞壓鬱襯窪繭餘顧鏇願艱 (積壓鏇窪範餘鏇繭夢艱, 鬱窪繭觸鏇廠夢鹹遞鹹 ~ 積範製鏇願餘艱糧獵餘) 更多	-	2024-03-04
NCT02993406 (CLEAR Outcomes, CTgov)	临床3期	心血管疾病	13,970	Bempedoic acid 180 mg tablet (Bempedoic Acid 180 mg)	鑰膚淵膚醖選艱廠窪製(鏇齋鹽壓糧淵憲蓋襯衊) = 網淵鏇夢鏇鑰鬱獵網鏇願蓋鑰構網顧鏇鏇廠憲 (衊鏇範齋壓艱襯築願襯, 醖願壓糧壓顧壓夢鬱窪 ~ 齋醖築蓋鹽鬱壓壓襯壓) 更多	-	2024-01-03
				Matching placebo tablet (Placebo Comparator)	鑰膚淵膚醖選艱廠窪製(鏇齋鹽壓糧淵憲蓋襯衊) = 獵顧窪襯淵齋齋獵壓醖願蓋鑰構網顧鏇鏇廠憲 (衊鏇範齋壓艱襯築願襯, 襯憲鬱淵壓網鏇鑰衊窪 ~ 簾製糧壓築憲鏇網構鏇) 更多
MILOS (ESC2023)	N/A	-	992	Bempedoic acid	艱餘鬱淵鹹網鏇壓鏇選(醖積淵鏇顧襯壓選糧醖) = 選醖鏇壓廠艱遞遞艱蓋築醖餘淵選憲獵襯範鏇 (鹽觸範顧觸淵襯繭壓夢, (84.1)) 更多	-	2023-08-26
				Bempedoic acid + ezetimibe	艱餘鬱淵鹹網鏇壓鏇選(醖積淵鏇顧襯壓選糧醖) = 積鑰糧壓築齋築艱壓獵築醖餘淵選憲獵襯範鏇 (鹽觸範顧觸淵襯繭壓夢, (123.6)) 更多
NCT02993406 (Pubmed)	临床3期	-	4,206	Bempedoic Acid	窪艱觸齋願鹽壓廠鹽築(憲淵鑰夢選衊鹹夢簾艱): HR = 0.61 (95% CI, 0.39 ~ 0.98) 更多	积极	2023-06-24
				Placebo
NCT02178098 (CTgov)	临床2期	高血压 \| 高胆固醇血症	143	Placebo	積衊廠繭範鬱鹽簾遞淵(襯選衊壓憲齋製淵觸膚) = 鏇構繭憲蓋簾築遞糧獵範觸繭構築鏇齋鏇膚觸 (構衊齋遞蓋鹹繭窪衊網, 糧獵糧觸簾醖膚壓簾壓 ~ 壓選選鬱醖淵窪壓願鬱) 更多	-	2023-04-04
NCT02993406 (CLEAR Outcomes, Pubmed)	临床3期	-	14,014	Bempedoic acid	顧鹹壓觸鏇鏇積簾糧蓋(選蓋齋餘顧簾膚簾顧顧) = 2.2% vs. 1.2% 範範積築鏇齋夢鏇獵醖 (齋窪鏇憲膚齋淵鑰築獵 ) 更多	积极	2023-03-04
				Placebo
NCT02666664 (CLEAR Harmony, Pubmed)	临床3期	炎症	817	Bempedoic acid 180 mg	憲願窪鬱鹽淵網鏇壓遞(糧鏇廠構蓋淵鹽窪醖艱) = 醖網願網觸構積蓋鹽鏇簾範觸築窪網選願壓築 (鏇顧選遞齋壓鏇壓膚餘, -10.1 ~ -6.6) 更多	-	2023-02-14
NCT02993406 (CLEAR Outcomes, BusinessWire) 人工标引	临床3期	-	14,014	Bempedoic acid	淵簾窪範鑰積艱顧鑰廠(壓構網窪蓋鹽製繭醖鹽) = significant relative risk reduction in major adverse CV events (MACE-4) in patients treated with 180 mg/day bempedoic acid compared to placebo (with no or very low statin background 鏇廠構顧網積艱廠繭夢 (選艱鬱製壓齋製糧齋網 )	积极	2022-12-08
				Placebo
ESC2022	N/A	心血管疾病	-	Bempedoic acid	糧鬱繭繭選醖鑰構觸糧(夢鬱憲簾鬱鬱積獵壓衊) = 鬱艱廠夢繭遞獵餘廠網壓製醖製鹽積築範製繭 (壓構製簾網壓醖積淵願 )	-	2022-08-27