Esperion Partner HLS Therapeutics Announces Approval of NILEMDO® for the Reduction of LDL-Cholesterol in Canadians at Risk of Cardiovascular Disease
Esperion (NASDAQ: ESPR) said partner HLS Therapeutics received Health Canada approval to market NILEMDO (bempedoic acid) for the reduction of LDL-cholesterol in Canadians at risk of cardiovascular disease.
Commercial launch in Canada is expected in Q2 2026. The announcement is positioned as part of Esperion's global strategy to expand access to bempedoic acid products.
The release cites Government of Canada figures that about 2.6 million adults (one in 12 aged 20+) live with diagnosed heart disease and that heart disease is the second leading cause of death in Canada, with roughly 14 adults aged 20+ dying every hour from diagnosed heart disease.
Esperion (NASDAQ: ESPR) ha dichiarato che il partner HLS Therapeutics ha ottenuto l'approvazione Health Canada per commercializzare NILEMDO (acido bempedoico) per la riduzione del colesterolo LDL nei canadesi a rischio di malattie cardiovascolari.
Il lancio commerciale in Canada è previsto nel secondo trimestre del 2026. L'annuncio è presentato come parte della strategia globale di Esperion per estendere l'accesso ai prodotti a base di acido bempedoico.
Il comunicato cita dati del Governo del Canada secondo cui circa 2,6 milioni di adulti (uno su 12 di età 20 anni o più) convivono con una malattia cardiaca diagnosticata e che la malattia cardiaca è la seconda causa di morte in Canada, con circa 14 adulti di età 20+ che muoiono ogni ora per malattia cardiaca diagnosticata.
Esperion (NASDAQ: ESPR) dijo que su socio HLS Therapeutics recibió la aprobación de Health Canada para comercializar NILEMDO (ácido bempedoico) para la reducción del colesterol LDL en canadienses con riesgo de enfermedad cardiovascular.
El lanzamiento comercial en Canadá se espera en el segundo trimestre de 2026. El anuncio se presenta como parte de la estrategia global de Esperion para ampliar el acceso a los productos de ácido bempedoico.
El comunicado cita cifras del Gobierno de Canadá que indican que aproximadamente 2,6 millones de adultos (uno de cada 12 mayores de 20 años) viven con una enfermedad cardíaca diagnosticada y que la enfermedad cardíaca es la segunda causa de muerte en Canadá, con aproximadamente 14 adultos mayores de 20 años que mueren cada hora por una enfermedad cardíaca diagnosticada.
Esperion (NASDAQ: ESPR)은 파트너 HLS Therapeutics가 헬스 캐나다의 시판 승인을 받아 심혈관 질환 위험이 있는 캐나다인의 LDL 콜레스테롤 감소를 위한 NILEMDO (벤페도익산)를 시장에 출시할 수 있게 되었다고 밝혔다.
캐나다에서의 상용 출시 예정은 2026년 2분기이다. 이번 발표는 벤페도익산 유도 제제에 대한 접근성을 확대하려는 Esperion의 글로벌 전략의 일부로 제시된다.
발표문은 캐나다 정부의 수치를 인용하며 약 260만 명(20세 이상 성인 중 12분의 1)가 진단된 심장 질환을 가지고 있으며, 심장 질환이 캐나다에서 두 번째로 높은 사망 원인이고 진단된 심장 질환으로 매시간 약 14명의 20세 이상 성인이 사망한다고 한다.
Esperion (NASDAQ: ESPR) a déclaré que son partenaire HLS Therapeutics a reçu l'autorisation de Santé Canada pour commercialiser NILEMDO (acide bempédéoïque) afin de réduire le cholestérol LDL chez les Canadiens à risque de maladie cardiovasculaire.
Le lancement commercial au Canada est prévu au deuxième trimestre 2026. L'annonce est présentée comme faisant partie de la stratégie mondiale d'Esperion visant à élargir l'accès aux produits à base d'acide bempédéoïque.
Le communiqué cite des chiffres du Gouvernement du Canada selon lesquels environ 2,6 millions d'adultes (un sur douze âgé de 20 ans et plus) vivent avec une maladie cardiaque diagnostiquée et que les maladies cardiaques constituent la deuxième cause de décès au Canada, avec environ 14 adultes âgés de 20 ans et plus qui meurent chaque heure d'une maladie cardiaque diagnostiquée.
Esperion (NASDAQ: ESPR) sagte, dass Partner HLS Therapeutics die Genehmigung von Health Canada erhalten hat, NILEMDO (Bempedonsäure) auf den Markt zu bringen, um den LDL-Cholesterinspiegel bei Kanadiern mit Risiko für Herz-Kreislauf-Erkrankungen zu senken.
Der kommerzielle Start in Kanada wird voraussichtlich im zweiten Quartal 2026 erfolgen. Die Ankündigung wird als Teil der globalen Strategie von Esperion zur Erweiterung des Zugangs zu Produkten auf Basis von Bempedonsäure dargestellt.
Die Mitteilung verweist auf Zahlen der kanadischen Regierung, wonach rund 2,6 Millionen Erwachsene (eine von zwölf Personen im Alter von 20 Jahren oder älter) mit diagnostizierten Herzerkrankungen leben und dass Herzerkrankungen die zweitgrößte Todesursache in Kanada sind, wobei etwa 14 Erwachsene ≥20 Jahre jede Stunde an einer diagnostizierten Herzerkrankung sterben.
Esperion (NASDAQ: ESPR) ذكرت أن شريكها HLS Therapeutics تلقى موافقة Health Canada لتسويق NILEMDO (حمض بيمبيدوئيك) لتقليل الكولسترول LDL لدى الكنديين المعرضين لخطر أمراض القلب والأوعية الدموية.
من المتوقع الإطلاق التجاري في كندا في الربع الثاني من 2026. يُقدَّم الإيلان كجزء من الاستراتيجية العالمية لـ Esperion لتوسيع الوصول إلى منتجات حمض بيمبيدوئيك.
ويستشهد البيان بأرقام من الحكومة الكندية تفيد بأن نحو 2,6 مليون بالغ (واحد من كل 12 من عمر 20 عامًا فأكثر) يعيشون مع مرض القلب التشخيصي وأن أمراض القلب هي ثاني سبب للوفاة في كندا، مع وفاة نحو 14 بالغًا من عمر 20 عامًا فما فوق كل ساعة بسبب مرض قلب تشخيصي.
- Health Canada approval secured for NILEMDO
- Commercial launch targeted for Q2 2026
- Potential market reach: 2.6 million Canadians with diagnosed heart disease
- None.
ANN ARBOR, Mich., Nov. 18, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that HLS Therapeutics Inc. (TSX: HLS), the Company’s partner in Canada for the development and commercialization of NILEMDO® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe), has received approval from Health Canada to market NILEMDO for the reduction of LDL-Cholesterol in Canadians at risk of cardiovascular disease. Commercial launch for NILEMDO is expected in Q2 2026.
“This approval marks another important milestone in our global strategy to expand access to bempedoic acid products for patients who urgently need better options to manage their LDL-C and reduce cardiovascular risk. We remain deeply committed to delivering innovative therapies that address unmet medical needs and improve outcomes for patients around the world,” said Sheldon Koenig, President and CEO of Esperion.
According to the Government of Canada, approximately one in 12 Canadian adults aged 20 and over, which represents 2.6 million people, are living with diagnosed heart disease. It is the second leading cause of death in Canada, with approximately 14 Canadian adults aged 20 and over dying every hour due to diagnosed heart disease.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms.
Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit esperion.com and follow Esperion on LinkedIn and X.
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, expected profitability, 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 profitability, 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.
Esperion Contact Information:
Investors:
Alina Venezia
investorrelations@esperion.com
(734) 887-3903
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Tiffany Aldrich
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FAQ
What did Esperion (ESPR) announce on November 18, 2025 about NILEMDO?
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