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First-In-Class Cholesterol-Lowering Treatment NILEMDO (NEXLETOL in the U.S.) and Its Combination With Ezetimibe, NUSTENDI (NEXLIZET in the U.S.), Approved In Europe To Treat Hypercholesterolemia and Significantly Reduce Cardiovascular Risk

First-In-Class Cholesterol-Lowering Treatment NILEMDO (NEXLETOL in the U.S.) and Its Combination With Ezetimibe, NUSTENDI (NEXLIZET in the U.S.), Approved In Europe To Treat Hypercholesterolemia and Significantly Reduce Cardiovascular Risk

同類首創的降膽固醇療法 NILEMDO(美國爲 NEXLETOL)及其與依澤替米貝、NUSTENDI(美國爲 NEXLIZET)的組合在歐洲獲准治療高膽固醇血癥並顯著降低心血管風險
GlobeNewswire ·  05/22 20:00

– NILEMDO (bempedoic acid), a First-In-Class, Oral Treatment and NUSTENDI (bempedoic Acid / Ezetimibe Fixed-Dose Combination) Receive Label Update Approval from The European Commission as Treatments to Reduce Cardiovascular Risk by Lowering Low-Density Lipoprotein Cholesterol (LDL-C) Levels –

— NILEMDO(bempedoic acid),同類首創的口服療法和NUSTENDI(本培多酸/依澤替米貝固定劑量組合)獲得歐盟委員會的標籤更新批准,可通過降低低密度脂蛋白膽固醇(LDL-C)水平來降低心血管風險 —

– This Makes Bempedoic Acid the First and Only LDL-C Lowering Treatment Indicated for Primary and Secondary Prevention of Cardiovascular Events –

— 這使得本培多酸成爲第一種也是唯一一種適用於心血管事件初級和二級預防的降低 LDL-C 的治療方法 —

– Up To 80% Of Patients Do Not Reach Guideline-Recommended LDL-C Goals Despite Receiving Treatments Such as Statins and Remain at an Increased Risk of a Heart Attack or Stroke and In Need of Additional Treatment –

— 儘管接受了他汀類藥物等治療,但仍有高達80%的患者仍未達到指南建議的低密度脂蛋白C目標,並且心臟病發作或中風的風險仍然增加,需要額外的治療—

ANN ARBOR, Mich. and MUNICH, Germany, May 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, 'Daiichi Sankyo') and Esperion Therapeutics, Inc. jointly announced today that the European Commission (EC) has approved the label update of both NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. The EC's decisions to update the labels of bempedoic acid and bempedoic acid / ezetimibe FDC are based on the positive CLEAR Outcomes trial results and makes them the first and only LDL-C lowering treatments indicated for primary and secondary prevention of cardiovascular events.

密歇根州安娜堡和德國慕尼黑,2024年5月22日(GLOBE NEWSWIRE)——第一三共歐洲有限公司(以下簡稱 “第一三共公司”)和Esperion Therapeutics, Inc.今天共同宣佈,歐盟委員會(EC)已批准兩款NILEMDO的標籤更新 (本培多酸)和 NUSTENDI (本培多酸/依澤替米貝固定劑量組合(FDC)),用於治療高膽固醇血癥(高膽固醇水平)和降低心血管不良事件的風險。歐盟委員會決定更新本培多酸和本培多酸/依則替米貝FDC的標籤,是基於CLEAR結果的積極試驗結果,這使它們成爲第一種也是唯一一種適用於心血管事件初級和二級預防的降低低密度脂蛋白C的治療方法。

The EC decisions follow the previous CHMP opinions received in March this year, and approved bempedoic acid and its fixed-dose combination (bempedoic acid / ezetimibe) for use in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors.

歐盟委員會的決定遵循了CHMP先前於今年3月收到的意見,批准了本培多酸及其固定劑量組合(bempedoic acid/ezetimibe),用於已確診或處於高風險的動脈粥樣硬化性心血管疾病的成年人,通過降低LDL-C水平來降低心血管風險,作爲糾正其他風險因素的輔助手段。

In Europe, around one in seven people have high LDL-C levels, and cardiovascular disease is the leading cause of death, responsible for more than 10,000 lives lost every day. However, up to 80% of patients do not reach guideline-recommended LDL-C goals despite receiving treatments such as statins and are at increased risk of a heart attack or stroke.

在歐洲,大約七分之一的人的低密度脂蛋白水平很高,心血管疾病是主要的死亡原因,每天造成超過10,000人死亡。但是,多達80%的患者儘管接受了他汀類藥物等治療,但仍未達到指南建議的低密度脂蛋白C目標,並且心臟病發作或中風的風險增加。

Bempedoic acid is a first-in-class oral treatment which lowers cholesterol, and which can be combined with other treatments to help lower cholesterol even further. Bempedoic acid provided additional cholesterol lowering of up to 28% on top of statin therapy, compared to placebo. Bempedoic acid / ezetimibe FDC combines two complementary ways of reducing cholesterol in a once-daily tablet, reduced LDL-C by 38% compared to placebo in high-risk patients already taking maximum-tolerated statin therapy.

Bempedoic acid 是一種首創的口服療法,可以降低膽固醇,並且可以與其他療法結合使用,進一步幫助降低膽固醇。與安慰劑相比,本培多酸在他汀類藥物治療的基礎上還能進一步降低膽固醇,最高可降低 28%。Bempedoic acid/ezetimibe FDC 在每天一次的片劑中結合了兩種降低膽固醇的互補方法,與安慰劑相比,已服用最大耐受性他汀類藥物的高危患者的低密度脂蛋白降低了 38%。

"Today's announcement marks a pivotal moment in our ongoing efforts to reduce cardiovascular risk. With the new indication, which covers both primary and secondary prevention, we can support healthcare professionals to better meet the treatment needs in their daily practice. At the same time, we're confident it will reassure patients that their medication truly addresses their CV risk. This reaffirms our commitment to be a trusted ally in improving cardiovascular care throughout Europe," said Oliver Appelhans, Head of Europe Specialty Division, Daiichi Sankyo Europe GmbH.

“今天的宣佈標誌着我們持續努力降低心血管風險的關鍵時刻。有了涵蓋初級和二級預防的新適應症,我們可以支持醫療保健專業人員更好地滿足日常實踐中的治療需求。同時,我們相信這將使患者放心,他們的藥物可以真正解決他們的心血管風險。這再次證實了我們致力於成爲改善整個歐洲心血管護理的值得信賴的盟友。” 第一三共歐洲有限公司歐洲專業部門負責人奧利弗·阿佩爾漢斯說。

"We are delighted with the European Commission's approval, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide," said Sheldon Koenig, President and CEO, Esperion. "This further supports our efforts towards delivering innovative treatment options to manage cardiovascular risk for patients with elevated LDL-C."

Esperion總裁兼首席執行官Sheldon Koenig表示:“我們對歐盟委員會的批准感到高興,這反映了本培多酸全球特許經營權爲全球患者帶來了顯著的心血管風險降低益處。”“這進一步支持我們努力提供創新的治療方案,以管理低密度脂蛋白升高患者的心血管風險。”

"Today's positive label update reaffirms the efficacy of both these treatments for reducing LDL-C levels and ultimately reducing patients' risk of serious cardiovascular events," said Professor Alberico Catapano, University of Milan, Italy. "The announcement will provide doctors across Europe with further confidence in prescribing bempedoic acid, alone or in combination with ezetimibe, for managing the needs of their patients."

意大利米蘭大學的阿爾貝里科·卡塔帕諾教授說:“今天的陽性標籤更新重申了這兩種療法在降低低密度脂蛋白水平和最終降低患者發生嚴重心血管事件風險方面的功效。”“該公告將使歐洲各地的醫生更有信心單獨或與依澤替米貝聯合開本培多酸處方,以管理患者的需求。”

EC approval is based on results of the Phase 3 CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes trial. The trial randomized a total of 13,970 patients aged 18–85 years old and was conducted at 1,250 sites in 32 countries, including 485 sites across Europe. Results from the Phase 3 CLEAR Outcomes trial demonstrated:

歐盟的批准基於3期CLEAR(通過Bempedoic Acid降低膽固醇,一種ATP檸檬酸裂解酶(ACL)抑制方案)結果試驗的結果。該試驗共對13,970名年齡在18-85歲之間的患者進行了隨機分配,在32個國家的1,250個研究中心進行,其中包括歐洲各地的485個地點。第三階段 CLEAR 結果試驗的結果表明:

  • a 13% reduction in the relative risk of major adverse cardiovascular events defined as a four-component composite of death from cardiovascular (CV) causes, non-fatal myocardial infarction, non-fatal stroke or coronary revascularization (MACE-4).
  • Results of the key secondary endpoints and subgroup analyses have also been published.
  • 重大心血管不良事件的相對風險降低了13%,這些事件的定義是心血管(CV)原因、非致命性心肌梗塞、非致命性中風或冠狀動脈血運重建(MACE-4)導致的死亡的四部分組合。
  • 關鍵次要終點和子組分析的結果也已公佈。

INDICATION
NEXLIZET and NEXLETOL are indicated:

指示
NEXLIZET 和 NEXLETOL 如下所示:

  • The bempedoic acid component of NEXLIZET and NEXLETOL is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:
    • established cardiovascular disease (CVD), or
    • at high risk for a CVD event but without established CVD.
  • As an adjunct to diet:
    • NEXLIZET, alone or in combination with other LDL-C lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
    • NEXLETOL, in combination with other LDL-C lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
  • NEXLIZET和NEXLETOL的本培多酸成分可用於降低無法接受推薦他汀類藥物治療的成年人(包括未服用他汀類藥物的成年人)發生心肌梗塞和冠狀動脈血運重建的風險,包括:
    • 已確診的心血管疾病 (CVD),或
    • 發生心血管疾病的風險很高,但尚未確立心血管疾病。
  • 作爲飲食的輔助手段:
    • NEXLIZET單獨使用或與其他降低低密度脂蛋白C的療法聯合使用,可降低包括HeFH在內的原發性高脂血症成人的低密度脂蛋白。
    • NEXLETOL與其他降低低密度脂蛋白C療法聯合使用,或者在無法同時進行低密度脂蛋白C降低療法時單獨使用,以降低包括HeFH在內的原發性高脂血症成人的低密度脂蛋白。

IMPORTANT SAFETY INFORMATION
NEXLIZET and NEXLETOL are contraindicated in patients with a prior hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported.

重要的安全信息
NEXLIZET和NEXLETOL禁用於先前對本培多酸、依折麥布或任何賦形劑過敏的患者。已經報道了嚴重的超敏反應,包括過敏反應、血管性水腫、皮疹和蕁麻疹。

Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels, which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.

高尿酸血癥: 本培多酸是NEXLIZET和NEXLETOL的成分,可能會增加血液中的尿酸水平,從而可能導致痛風。高尿酸血癥可能在治療初期發生,並在整個治療過程中持續存在,在停止治療後恢復到基線。按照臨床指示定期評估尿酸水平。監測高尿酸血癥的體徵和症狀,並酌情開始使用降尿酸藥物進行治療。

Tendon Rupture: Bempedoic acid, a component of NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.

肌腱斷裂: Bempedoic acid 是 NEXLIZET 和 NEXLETOL 的成分,與肌腱斷裂或受傷的風險增加有關。肌腱斷裂可能更常見於60歲以上的患者、服用皮質類固醇或氟喹諾酮藥物的患者、腎衰竭患者以及以前患有肌腱疾病的患者。在肌腱斷裂的第一個跡象時停用 NEXLIZET 或 NEXLETOL。對於有肌腱疾病或肌腱斷裂史的患者,可以考慮使用替代療法。

The most common adverse reactions in the primary hyperlipidemia trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, in ≥2% of patients and greater than placebo were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes.

在 ≥ 2% 的患者中,本培多酸(NEXLIZET和NEXLETOL的成分)原發性高脂血症試驗中最常見的不良反應是上呼吸道感染、肌肉痙攣、高尿酸血癥、背痛、腹痛或不適、支氣管炎、四肢疼痛、貧血和肝酶升高。

Adverse reactions reported in ≥2% of patients treated with ezetimibe (a component of NEXLIZET) and at an incidence greater than placebo in clinical trials were upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza.

在接受依澤替米貝(NEXLIZET的一種成分)治療的患者中,有≥2%報告的不良反應是上呼吸道感染、腹瀉、關節痛、鼻竇炎、四肢疼痛、疲勞和流感,在臨床試驗中發生率高於安慰劑。

In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence ≥3% and greater than placebo) observed with NEXLIZET, but not observed in clinical trials of bempedoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation.

在NEXLIZET的原發性高脂血症試驗中,NEXLIZET觀察到的最常報告的不良反應(發生率≥3%,高於安慰劑),但在本培多酸或依澤替米布的臨床試驗中未觀察到的不良反應是尿路感染、鼻咽炎和便秘。

The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of ≥2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.

本培多酸(NEXLIZET和NEXLETOL的一種成分)的心血管預後試驗中最常見的不良反應是高尿酸血癥、腎功能受損、貧血、肝酶升高、肌肉痙攣、痛風和膽石症,其發生率分別爲高尿酸血癥、腎功能受損、貧血、肝酶升高、肌肉痙攣、痛風和膽石症。

Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL.

除非治療的益處大於對胎兒的潛在風險,否則應在確認懷孕後停用NEXLIZET或NEXLETOL。由於母乳餵養的嬰兒可能會出現嚴重的不良反應,因此在使用NEXLIZET或NEXLETOL治療期間不建議母乳餵養。

Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.

向Esperion Therapeutics, Inc.不良事件報告熱線1-833-377-7633報告懷孕情況。

Please see full Prescribing Information for NEXLIZET and NEXLETOL.

請查看完整的處方信息 NEXLIZETNEXLETOL

Esperion Therapeutics
At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life's work. For more information, visit esperion.com and esperionscience.com and follow us on X at twitter.com/EsperionInc.

Esperion Therapeu
在Esperion,我們發現、開發和商業化創新藥物,以幫助改善心血管和心臟代謝疾病患者或有風險患者的預後。現狀無法滿足數百萬高膽固醇患者的健康需求——這就是爲什麼我們充滿激情的行業領導者團隊正在突破阻礙患者實現目標的障礙。醫療服務提供者正在努力盡快將低密度脂蛋白膽固醇水平降低到儘可能低的水平;我們提供了下一步措施以幫助患者達到這一水平。因爲當涉及到高膽固醇時,達到目標不是可選的。這是我們一生的工作。欲了解更多信息,請訪問 esperion.com 和 esperionscience.com,然後在 X 上關注我們,網址爲 twitter.com/esperionINC。

CLEAR Cardiovascular Outcomes Trial
CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL(bempedoic acid) Tablet and NEXLIZET (bempedoic acid and ezetimibe) Tablet. The CLEAR Program seeks to generate important clinical evidence on the safety and efficacy of bempedoic acid, a first in a class ATP citrate lyase inhibitor contained in NEXLETOL and NEXLIZET and its potential role in addressing additional critical unmet medical needs. More than 60,000 people will have participated in the program by the time of its completion. The CLEAR Program includes 5 label-enabling Phase III studies as well as other key Phase IV studies with the potential to reach more than 70 million people with or at risk for CVD based on elevated LDL-C.

CLEAR 心血管結果試
CLEAR 結果是 NEXLETOL CLEAR 臨床研究計劃的一部分(苯哌多酸)片劑和 NEXLIZET (本培多酸和依澤替米貝)片劑。CLEAR計劃旨在提供有關本培多酸的安全性和有效性的重要臨床證據,本培多酸是NEXLETOL和NEXLIZET中所含的同類首款ATP檸檬酸裂解酶抑制劑,以及其在解決其他未滿足的關鍵醫療需求方面的潛在作用。到該計劃完成時,將有超過60,000人蔘與該計劃。CLEAR計劃包括5項支持標籤的III期研究以及其他重要的IV期研究,這些研究有可能惠及超過7000萬基於LDL-C升高的心血管疾病患者或有心血管疾病風險的人。

Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion's commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

前瞻性陳述
本新聞稿包含根據聯邦證券法安全港條款做出的前瞻性陳述,包括有關營銷戰略和商業化計劃、當前和計劃運營支出、未來運營、商業產品、臨床開發的聲明,包括CLEAR Outsups研究的時間安排、設計和計劃及其結果、潛在未來候選產品的計劃、財務狀況和前景,包括預期的現金跑道,以及其他包含 “” 字樣的陳述預測”、“相信”、“估計”、“期望”、“打算”、“可能”、“計劃”、“預測”、“項目”、“建議”、“目標”、“潛在”、“將”、“可能”、“應該”、“繼續” 和類似的表達。本新聞稿中包含的任何非歷史事實陳述的明示或暗示陳述均可被視爲前瞻性陳述。前瞻性陳述涉及風險和不確定性,可能導致Esperion的實際業績與預期有很大差異,包括但不限於Esperion商業產品的淨銷售額、盈利能力和增長、臨床活動和結果、供應鏈、商業開發和啓動計劃、法律訴訟和和解的結果和預期收益,以及Esperion向美國證券交易委員會提交的文件中詳述的風險。本新聞稿中包含的任何前瞻性陳述僅代表截至本新聞稿發佈之日,除法律要求外,Esperion不承擔任何更新或修改本新聞稿中包含的任何前瞻性陳述的義務或承諾。

Media Contacts:
For Esperion: For Daiichi Sankyo Europe:
Investors: Investor Relations Contact (Japan):
investorrelations@esperion.com DaiichiSankyoIR@daiichisankyo.co.jp
Media: Dr. Wolfgang Schiessl (Europe)
Tiffany Aldrich wolfgang.schiessl@daiichi-sankyo.eu
corporateteam@esperion.com +49 151 1714 7317
(616) 443-8438
Sean Wood (Global / US)
swood@webershandwick.com
+1 (212) 445-8310
媒體聯繫人:
對於 Esperion: 對於歐洲第一三共來說:
投資者: 投資者關係聯繫人(日本):
investorrelations@esperion.com DaiichiSankyoIR@daiichisankyo.co.jp
媒體: 沃爾夫岡·席斯爾博士(歐洲)
蒂芙尼奧爾德里奇 wolfgang.schiessl@daiichi-sankyo.eu
corporateteam@esperion.com +49 151 1714 7317
(616) 443-8438
肖恩·伍德(全球/美國)
swood@webershandwick.com
+1 (212) 445-8310

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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