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Esperion Announces New Drug Submissions in Canada for NEXLETOL (Bempedoic Acid) and NEXLIZET (Bempedoic Acid and Ezetimibe) Treatments to Reduce LDL-C and Cardiovascular Risk

Esperion Announces New Drug Submissions in Canada for NEXLETOL (Bempedoic Acid) and NEXLIZET (Bempedoic Acid and Ezetimibe) Treatments to Reduce LDL-C and Cardiovascular Risk

Esperion公司在加拿大宣佈了針對NEXLETOL(貝美託酸)和NEXLIZEt(貝美託酸和依澤替米貝)治療的新的藥物申請,以降低低密度脂蛋白膽固醇(LDL-C)和心血管風險。
GlobeNewswire ·  12/02 21:00

ANN ARBOR, Mich., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has filed New Drug Submissions (NDSs) to Health Canada for NEXLETOL and NEXLIZET, once-daily, accessible, oral non-statin medications that reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.

密歇根州安娜堡,2024年12月02日(環球新聞)-- esperion therapeutics(納斯達克:ESPR)今天宣佈已向加拿大衛生部提交了NEXLETOL和NEXLIZEt的新藥申請(NDS),這是一種每日一次、易於使用的口服非他汀類藥物,用於降低低密度脂蛋白膽固醇(LDL-C)和心血管風險。

"These submissions mark another pivotal milestone towards bringing our potentially lifesaving medications to the millions of patients around the world who need it," said Sheldon Koenig, President and CEO of Experion. "Heart disease remains the number one cause of death globally, so we look forward to the opportunity to provide NEXLETOL and NEXLIZET as LDL cholesterol lowering and cardiovascular risk reduction treatment options for healthcare providers and patients in Canada."

"這些申請標誌着向將我們可能挽救生命的藥物帶給全球數百萬需要它的患者邁出的又一個關鍵里程碑,"esperion therapeutics的總裁兼首席執行官謝爾頓·科寧(Sheldon Koenig)說。"心臟病仍然是全球首要的死亡原因,因此我們期待能夠爲加拿大的醫療保健提供者和患者提供NEXLETOL和NEXLIZEt作爲降低LDL膽固醇和減少心血管風險的治療選擇。"

According to the Public Health Agency of Canada (PHAC), heart disease is the second leading cause of death in Canada. Data from the Canadian Chronic Disease Surveillance System (CCDSS) from 2017-2018 showed that approximately 1 in 12 (or approximately 2.6 million) Canadian adults aged 20 and over live with diagnosed heart disease and every hour, approximately 14 Canadian adults aged 20 and over with diagnosed heart disease die.1

根據加拿大公共衛生局(PHAC)的數據,心臟病是加拿大第二大死亡原因。2017-2018年的加拿大慢性病監測系統(CCDSS)數據顯示,約每12名(或約260萬)20歲及以上的加拿大成年人中就有1人被診斷爲心臟病,並且每小時大約有14名20歲及以上的被診斷爲心臟病的加拿大成年人死亡。

INDICATION
NEXLIZET and NEXLETOL are indicated:

適應症
NEXLIZET和NEXLETOL的適應症爲:

  • 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的貝普多酸成分適用於無法服用推薦他汀類藥物療法(包括不服用他汀類藥物的患者)且伴有以下情況的成年人,可減少心肌梗死和冠狀動脈重建術的風險:
    • 已確診心血管疾病(cvd設備)或
    • 面臨發生心血管疾病事件的高風險人群,但尚未確診心血管疾病。
  • 作爲飲食的輔助:
    • NEXLIZEt,單獨或與其他降低LDL-C的療法結合,用於降低成人原發性高脂血症,包括HeFH中的LDL-C。
    • NEXLETOL,聯合其他降低LDL-C的療法使用,或在無法同時進行LDL-C降低療法時單獨使用,用於降低成人原發性高脂血症,包括HeFH中的LDL-C。

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.

重要安全信息
對於曾有苯吡地酸或依澤替米布或其任何輔料過敏的患者,NEXLIZEt和NEXLETOL屬於禁忌症。已報道嚴重過敏反應,包括過敏性休克、血管水腫、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:NEXLIZEt和NEXLETOL的成分苯吡多酸可能會增加血尿酸水平,從而導致痛風。治療早期可能出現高尿酸血癥,整個治療期間可能持續存在,停藥後會回到基線水平。根據臨床指徵定期評估尿酸水平。密切監測高尿酸血癥的體徵和症狀,並根據需要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.

腱破裂:NEXLIZEt和NEXLETOL的成分苯吡多酸與腱破裂或損傷的風險增加有關。腱破裂可能更常見於60歲以上的患者,那些正在服用皮質類固醇或氟喹諾酮類藥物的患者,腎功能衰竭患者,以及有腱疾病史的患者。首次出現腱破裂跡象時停止服用NEXLIZEt或NEXLETOL。對於有腱疾病或腱破裂史的患者,考慮替代療法。

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.

苯吡多酸在NEXLIZEt和NEXLETOL的原發性高脂血症試驗中最常見的不良反應,出現在患者中佔≥2%比例,並且明顯高於安慰劑的有上呼吸道感染、肌痙攣、高尿酸血癥、背痛、腹部疼痛或不適、支氣管炎、四肢疼痛、貧血和肝酶增高。

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.

在臨床試驗中,ezetimibe(NEXLIZET的成分)治療的患者中,≥2%的患者報告的不良反應,且發生率高於安慰劑的有上呼吸道感染、腹瀉、關節痛、鼻竇炎、四肢疼痛、疲勞和流感。

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的原發性高脂蛋白血癥試驗中,與貝米多酸或依折麥布的臨床試驗中未觀察到的尿道感染,鼻咽炎和便秘是使用NEXLIZEt報告的最常見的不良反應(發生率≥3%且高於安慰劑)。

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.

在貝米多酸心血管結局試驗中最常見的不良反應(發生率≥2%且高於安慰劑0.5%)包括高尿酸血癥,腎功能受損,貧血,肝酶升高,肌肉痙攣,痛風和膽結石,貝米多酸是NEXLIZEt和NEXLETOL的組成部分。

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.

如果懷孕,請停止使用NEXLIZEt或NEXLETOL,除非治療的好處大於對胎兒的潛在風險。由於哺乳期嬰兒可能出現嚴重不良反應,不建議在使用NEXLIZEt或NEXLETOL期間哺乳。

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

請將懷孕情況報告給esperion therapeutics公司不良事件報告電話1-833-377-7633。

Please see full Prescribing Information for NEXLIZET and NEXLETOL.

請查閱NEXLIZEt和NEXLETOL的完整處方信息。

Esperion Therapeutics

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.

在Esperion,我們發現,開發和商業化創新藥物,幫助改善患有或處於心血管和心臟代謝疾病風險的患者的預後。現狀不能滿足數以百萬計的高膽固醇患者的健康需要——這就是爲什麼我們的充滿激情的行業領袖團隊正在突破阻礙患者實現目標的障礙。提供商正在向將低密度脂蛋白膽固醇水平降至可能的最低水平邁進;我們提供幫助患者達到目標的下一步。因爲在處理高膽固醇時,達到目標不是可選的。這是我們的畢生事業。有關更多信息,請訪問esperion.com。esperion.comesperionscience.com(COVID-19疫苗,mRNA)(BNT162b2),包括一種Omicron適應性單價COVID-19疫苗候選者,基於JN.1譜系,包括向歐洲藥品管理局(EMA)提交一種基於JN.1譜系的Omicron適應性單價COVID-19疫苗,有關COVID-19疫苗的需求預期,計劃的監管提交,可用數據的定性評估,潛在的好處,臨床試驗的預期,潛在的監管提交,預期的數據讀數時間,監管提交,監管批准或授權以及預期的大規模製造、分銷和供應。這些都涉及到大量的風險和不確定性,可能導致實際結果與這些聲明所表達或暗示的結果有重大差異。風險和不確定性包括但不限於研究和開發的不確定性,包括滿足預期的臨床終點,開始和/或完成臨床試驗的日期,監管提交日期,監管批准日期和/或上市日期,以及有關兒童、青少年或成人的任何單價或雙價疫苗候選者或BNT162項目中的任何其他疫苗候選者的我們所有研究中的任何數據(包括1/2/3期或4期數據),包括本公告中爲BNT162b2、任何單價或雙價疫苗候選者或BNT162計劃中的任何其他疫苗候選者或任何實際證據的數據,包括可能的不利新的臨床前、臨床或安全數據和現有臨床前、臨床或安全數據的進一步分析;能否產生可比的臨床或其他結果,包括迄今爲止觀察到的疫苗有效性和安全性以及可耐受性;任何其他次生效應的觀察來分析臨床或其他數據;能否在更大、更多樣化的人群中進行實際數據研究分析或在發刊之前的進一步分析中產生可比的臨床或其他結果;BNT162b2、任何單價或雙價疫苗候選者或任何未來疫苗能否預防因新興病毒變種引起的COVID-19;使用疫苗更加廣泛會不會提供關於疫苗的新信息,包括效力、安全性或其他方面的信息,包括產生額外嚴重不良反應的風險;臨床前和臨床試驗數據的風險和不確定性,包括科學界的同行評審或出版過程期間的對數據進行的不同解釋和評估以及監管機構的評估;BNT162 mRNA疫苗程序的任何其他數據是否會在科學期刊中出版,如果出版,何時以及在進行何種修改和解釋;監管機構是否會對這些和任何未來臨床前和臨床研究的設計和結果感到滿意;以及提交請求爲BNT162b2在其他人群中請求緊急使用或有條件銷售授權、爲BNT162b2、任何單價或雙價疫苗候選者向特定司法轄區提交任何其他生物許可和/或緊急使用授權申請或修改任何該等申請的時機和是否提交,以及如果獲得,在何時將出現這樣的緊急使用授權或許可;提交請求BNT162b2(包括任何緊急使用或有條件銷售授權的請求的修正),任何單價或雙價疫苗候選者(包括基於JN.1譜系的Omicron適應性單價COVID-19疫苗的提交給EMA),或BNT162計劃可能會產生的其他疫苗的任何申請是否會得到特定監管機構的批准,這將取決於無數因素,包括是否作出決定認爲該疫苗的益處超過其已知的風險,以及該疫苗的功效,並且如果獲得批准,它是否會獲得商業上的成功;監管機構是否會有影響標籤或營銷、製造過程、安全和/或其他事項的決定,這些決定可能影響疫苗可用性或商業潛力,包括其他公司開發產品或療法;我們與合作伙伴、臨床試驗網站或第三方供應商的關係出現中斷的風險;任何產品的需求量可能會減少或不再存在或不能滿足預期,這可能導致營收減少或手頭和/或渠道管道中存在過量庫存,對於我們的COVID-19疫苗,2023年產生了顯着的庫存減值,可能繼續導致庫存減值或其他意外費用;關於我們的COVID-19疫苗向商業市場的轉型存在挑戰;與公衆接種疫苗、加強劑、治療方案或組合相關的挑戰;關於我們能否準確預測或實現我們對我們的COVID-19疫苗或任何潛在未來COVID-19疫苗的營收預測的不確定性;涉及我們的COVID-19疫苗產生第三方版稅或其他索賠的風險;其他公司可能會生產出更優秀或競爭性的產品的風險;涉及獲得原材料進行疫苗製造或測試的風險;與我們疫苗的配方、劑量時間表以及相應的存儲、分銷和管理要求相關的挑戰,包括涉及輝瑞交付後的存儲和處理的風險;我們可能無法成功開發其他疫苗配方、加強劑或潛在未來的年度加強劑或補種,或基於新變種的疫苗;我們可能無法按時保持或擴大製造能力,或按與全球對我們的疫苗的需求相符的時間表,保持物流或供應渠道的訪問,這將對我們在預期時間範圍內提供疫苗預估的劑量數產生負面影響,以前述所示;是否會達成額外供應協議存在不確定性;能否獲得來自疫苗諮詢或技術委員會以及其他公共衛生機構的建議存在不確定性,以及任何此類建議的商業影響的不確定性;與公衆對疫苗信心或認識有關的挑戰;關於COVID-19對輝瑞業務、運營和財務結果的影響的不確定性;以及競爭發展。twitter.com/EsperionInc。

Forward-Looking Statements

前瞻性聲明

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.

本新聞稿包含根據聯邦證券法安全港條款而進行的前瞻性陳述,包括關於營銷策略和商業化計劃、當前和計劃中的運營支出、未來運營、商業產品、臨床發展,包括CLEAR Outcomes研究的時間安排、設計和計劃以及其結果、潛在未來產品候選者的計劃、財務狀況和展望,包括預期的現金支持期限,以及其他包含"預期"、"相信"、"估計"、"期望"、"打算"、"可能"、"計劃"、"預測"、"項目"、"建議"、"目標"、"潛在"、"將"、"將會"、"可能"、"應該"、"繼續"等詞語的陳述。本新聞稿中的任何明示或暗示的非歷史事實陳述可能被視爲前瞻性陳述。前瞻性陳述涉及風險和不確定性,可能導致esperion的實際結果與預測顯著不同,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、商業發展和推出計劃、法律訴訟和和解的結果和預期收益,以及在證券交易委員會提交的風險詳細信息中。本新聞稿中包含的任何前瞻性陳述僅於本文日期,esperion除法律要求外,不負任何更新或修訂本新聞稿中包含的前瞻性陳述的責任或義務。

Esperion Contact Information:
Investors:
Alina Venezia
investorrelations@esperion.com
(734) 887-3903

Esperion聯繫信息:
投資者:
Alina Venezia
investorrelations@esperion.com
(734) 887-3903

Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438

媒體:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438

1 . Accessed Nov. 19, 2024.

1 . 訪問日期 2024年11月19日。


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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