Press Release

ONTARIO AND QUEBEC EXPAND PUBLIC COVERAGE OF REPATHA® FOR ELIGIBLE RECENT ACUTE CORONARY SYNDROME PATIENTS

MISSISSAUGA, ON, April 7, 2026 /CNW/ – Amgen Canada announced today that the Governments of Ontario and Quebec have expanded public reimbursement of Repatha® (evolocumab injection) for eligible patients following an acute coronary syndrome (ACS). Repatha is approved as an adjunct to diet and standard-of-care therapy, to reduce the risk of heart attack, stroke, and coronary revascularization in adults with atherosclerotic cardiovascular disease.1

In Ontario, updated coverage through the Ontario Drug Benefit (ODB) program includes eligible patients within 52 weeks of an ACS who are not meeting cholesterol targets despite standard lipid-lowering therapies.2 Full reimbursement criteria and information can be found by consulting the ODB program for details.

In Quebec, Repatha was publicly listed for ACS on February 4, making it the first province to do so.3 This includes coverage for eligible patients up to 24 months following an ACS who are not meeting cholesterol targets despite standard lipid-lowering therapies. Full reimbursement criteria and details are available in the Régie de l’assurance maladie du Québec (RAMQ) formulary.

“Quebec’s pioneering role in expanding access to care for patients who have suffered an acute coronary syndrome reflects a growing focus on managing cardiovascular risk following a cardiac event,” said Dr. Jean C. Grégoire, Interventional Cardiologist at the Montreal Heart Institute. “It is essential that other provinces continue their efforts to ensure more patients have access to appropriate and effective treatment following an event.”

“Public funding for Repatha is incredibly meaningful for patients following an acute coronary syndrome,” said Daniel Jun Martinez, Executive Medical Director of Amgen Canada. “Extending coverage and broadening eligibility could help more patients access appropriate lipid-lowering therapy early after an acute event, when timely treatment may be critical for reducing future cardiovascular risk.”4,5

Patients who experience an ACS face a substantially elevated risk of recurrent cardiovascular events, particularly in the first few years following the initial event.6 In Ontario, 42 per cent of patients with a history of an ACS remain above the Canadian lipid guideline-recommended LDL-C threshold despite treatment.7 Among Canadian patients with ASCVD who subsequently experience an ACS and remain above the LDL-C threshold of 1.8 mmol/L despite statin therapy, nearly half will experience another cardiovascular event within 3.4 years, and one in four will die from cardiovascular causes.8 Canadian Cardiovascular Society guidelines recommend additional lipid-lowering treatment when LDL-C remains above 1.8 mmol/L following an ACS, to reduce the risk of subsequent events.9

“After leaving the hospital, patients still need ongoing treatment to support their heart health,” said Dr. Shaun Goodman, Associate Head of Cardiology at St. Michael’s Hospital. “Lowering LDL cholesterol is a critically important part of that care, and access to appropriate therapies helps ensure patients receive the standard-of-care treatment recommended by their physicians.”

Each year, more than 60,000 Canadians experience their first heart attack10 and another 158,000 are diagnosed with coronary artery disease,11 a condition that causes plaque to build up in the arteries, reducing blood flow and increasing the risk of future cardiovascular events.12

“Following an acute coronary syndrome, patients remain at high risk for another cardiovascular event, particularly when LDL-C levels remain elevated,”13 said Dr. Jeffrey Habert, family physician and Assistant Professor at the University of Toronto. “Expanding access to additional lipid-lowering therapies gives clinicians the opportunity to act sooner and help patients avoid potentially preventable future events.”

About Repatha (evolocumab)

Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). By preventing PCSK9-mediated degradation of LDL receptors, Repatha increases the liver’s ability to remove LDL-C (“bad cholesterol”) from the bloodstream.

Globally, Repatha has 8.5M patients and has been studied in more than 50 clinical trials involving over 57,000 patients and is approved in over 70 countries.14,15,16 It is administered via a single-use prefilled SureClick® autoinjector.

IMPORTANT SAFETY INFORMATION 

  • Contraindications: 
    Hypersensitivity to Repatha or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container. Refer to the Contraindications section of the relevant product monographs of any concomitant lipid-lowering medications
  • Relevant warnings and precautions: 
    Refer to the Warnings and Precautions section of the relevant product monographs of any concomitant lipid-lowering medications. Hypersensitivity reactions (e.g., rash, urticaria, angioedema) have been reported. If signs or symptoms of serious allergic reactions occur, discontinue Repatha and treat according to standard of care and monitor until signs and symptoms resolve. No studies have been conducted with Repatha in pregnant women or nursing women and relevant data from clinical use are very limited. There is no information regarding the presence of evolocumab in human milk, the effects on the breastfed infant, or the effects on milk production; a risk to breastfed infants cannot be excluded. Statin product monographs recommend discontinuation when a patient becomes pregnant, therefore Repatha should also be discontinued. Data on efficacy and safety in HoFH patients aged 10-11 years are limited. Efficacy and safety have not been established in pediatric patients <10 years of age with HeFH, HoFH or in pediatric patients with other types of hyperlipidemia. Use with caution in patients with severe renal impairment. Use with caution in patients with severe hepatic impairment. The autoinjector is not made with natural rubber latex. Effects of Repatha in patients with or at risk of hepatitis C virus infection remain uncertain.
  • For more information: 
    Consult the Product Monograph at www.amgen.ca/Repatha_PM.pdf for important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece.

For the Product Monograph and questions about Repatha, contact Amgen Canada Medical Information at 1-866-502-6436 or visit www.amgenmedinfo.ca

About Amgen Canada
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ontario’s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new uses for existing medicines in partnership with many of Canada’s leading healthcare, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.

Amgen’s Commitment to Cardiovascular Innovation

Cardiovascular disease (CVD) remains a major global health threat, linked to multiple interrelated risk factors like high LDL-C, Lp(a), obesity, diabetes and hypertension. These risks often coexist and require a comprehensive approach to prevention and care. Amgen is taking bold action, building on decades of leadership in CVD through LDL-C management to advance additional innovative, investigational treatments in the pipeline targeting common drivers of CVD. By combining scientific innovation with strategic partnerships to drive earlier testing, better care and broader access, Amgen’s efforts reflect a sustained commitment to advancing both the science and the system of CV care.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast), Amgen’s acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon’s business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on Amgen’s business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

Amgen’s results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of Amgen’s products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen’s business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen’s business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen’s manufacturing activities, the distribution of Amgen’s products, the commercialization of Amgen’s product candidates, and Amgen’s clinical trial operations, and any such events may have a material adverse effect on Amgen’s product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen’s products are supplied by sole third-party suppliers. Certain of Amgen’s distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen’s efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. There can be no guarantee that Amgen will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. Amgen may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of Amgen’s information technology systems could compromise the confidentiality, integrity and availability of Amgen’s systems and Amgen’s data. Amgen’s stock price may be volatile and may be affected by a number of events. Amgen’s business and operations may be negatively affected by the failure, or perceived failure, of achieving its sustainability objectives. The effects of global climate change and related natural disasters could negatively affect Amgen’s business and operations. Global economic conditions may magnify certain risks that affect Amgen’s business. Amgen’s business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

CONTACT: 
Phynicia Choy
[email protected]
416-628-4110

____________________________________

1 https://www.amgen.ca/en-ca/about/-/media/themes/corporateaffairs/redesign/amgen-ca/amgen-ca/pdf/products/en/en-repatha-pm.pdf

2 https://www.ontario.ca/files/2026-03/moh-ontario-drug-benefit-odb-formulary-edition-43-summary-en-2026-03-24.pdf

3 https://www.ramq.gouv.qc.ca/sites/default/files/documents/non_indexes/liste-med-2026-02-04-en.pdf

4 Mackinnon E, et al. Cardiol Ther. 2024; 13:205–220

5 Pearson GJ et al. Can J Cardiol. 2021;37:1129-50

6 Mackinnon E, et al. Cardiol Ther. 2024; 13:205–220

7 Langer A, et al. Cardiol Vasc Res. 2023

8 Mackinnon E, et al. Cardiol Ther. 2024; 13:205–220)

9 Pearson GJ et al. Can J Cardiol. 2021;37:1129-50.

10 Public Health Agency of Canada. Heart Disease in Canada: Highlights from the Canadian Chronic Disease Surveillance System, 2023. Government of Canada; 2023. Accessed October 24, 2025. https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/diseases-conditions/heart-disease-fact-sheet/heart-disease-factsheet-eng.pdf

11 Public Health Agency of Canada. Heart Disease in Canada: Highlights from the Canadian Chronic Disease Surveillance System, 2023. Government of Canada; 2023. Accessed October 24, 2025. https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/diseases-conditions/heart-disease-fact-sheet/heart-disease-factsheet-eng.pdf

12 Heart and Stroke Foundation of Canada. Coronary Artery Disease. Heart & Stroke Foundation; 2025. Accessed October 24, 2025. https://www.heartandstroke.ca/heart-disease/conditions/coronary-artery-disease

13 Mackinnon E, et al. Cardiol Ther. 2024; 13:205–220

14 Stein EA, Wasserman SM, Dias C, Scott R, Raal F. AMG-145. Drugs of the Future. 2013;38(7):0451.

15 Data on file, Amgen. 2025.

16 Data on file, Amgen. 2025.

SOURCE Amgen Canada

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