Findings Represent Largest and Most Rigorous Head-to-Head Real-World Outcomes Analysis of Repatha and Ezetimibe 

Study Examined More Than Half a Million Adults Living with Heart Disease

Results Provide Important New Clinical Evidence to Inform Non-Statin Treatment Decisions for Patients 

THOUSAND OAKS, Calif., Nov. 5, 2026 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced results from a large real-world study showing that treatment with Repatha^® (evolocumab) reduced the risk of fatal or nonfatal heart attacks by 20% compared with ezetimibe in people with atherosclerotic cardiovascular disease (ASCVD) and prior statin use. The study followed more than 544,000 adults for up to four years. The findings were published in The American Journal of Preventive Cardiology.

“We have known for decades that lowering LDL cholesterol reduces cardiovascular risk, yet many patients with ASCVD cannot reach recommended levels with statins alone,” said Paul Burton, M.D., Ph.D., chief medical officer at Amgen. “For physicians deciding what treatment to add next, whether that’s prescribing patients Repatha or ezetimibe, this large real-world study provides clear evidence to help inform that choice. Patients who received Repatha had a 20% lower risk of heart attack or death from a heart attack compared with those who received ezetimibe.”

Among patients with a baseline low-density lipoprotein cholesterol (LDL-C) measurement (N = 225,048), the four-year cumulative risk of heart attack was lower with Repatha than with ezetimibe, an oral medicine that lowers LDL-C by limiting cholesterol absorption (5.88% vs. 7.76%). The analysis compared cardiovascular outcomes across a large patient population using rigorous analytical methods. The study is distinctive in its scale and approach to analyzing outcomes in the real world, requiring precise investigative methods to provide a large, practical evidence base that evaluates cardiovascular outcomes between the two treatments. Its findings provide a practical real-world complement to clinical trial evidence and may help inform clinical practice.

“While the recent ACC/AHA Multisociety Guideline update recognizes both ezetimibe and PCSK9 inhibitors like evolocumab as non-statin options for patients with ASCVD, clinicians have lacked direct cardiovascular outcomes evidence to help inform treatment choices for their patients that may allow them to fully achieve the recommended LDL-C goals of <70 mg/dL and <55 mg/dL,” said Nihar Desai, M.D., M.P.H., associate professor of medicine and vice chief of the Section of Cardiovascular Medicine, Yale University School of Medicine. “These findings provide important comparative data that can help clinicians distinguish between these treatment options and make more informed choices to reduce their patients’ cardiovascular risk.”

This real-world study used a rigorous design that mirrors a randomized clinical trial to compare cardiovascular outcomes among adults with ASCVD who initiated Repatha or ezetimibe in routine U.S. clinical practice. The analysis leveraged de-identified data from the Komodo Healthcare Map^® and applied a robust analytical approach to ensure that the two treatment groups were as similar as possible with respect to their baseline patient characteristics.

About the Real-World Comparative Study
The Real-World Comparative Effectiveness of Evolocumab Versus Ezetimibe in Adults with Atherosclerotic Cardiovascular Disease: An Active-Comparator New-User Study is a non-interventional, active-comparator, new-user cohort study that applied a target trial framework to compare cardiovascular outcomes among adults with ASCVD and prior statin use who initiated evolocumab or ezetimibe in routine U.S. clinical care. The study included 544,103 adults identified in the Komodo Healthcare Map^® database, including 64,421 who initiated evolocumab and 479,682 who initiated ezetimibe between 2017 and 2024, with follow-up through June 2026. The primary outcome was fatal or nonfatal myocardial infarction (MI) over up to four years of follow-up.

Treatment with evolocumab lowered the rate of fatal or nonfatal MI by 20% compared with ezetimibe (HR, 0.80; 95% CI, 0.70-0.91). Among patients without an available baseline LDL-C measurement, the corresponding four-year cumulative risks were 5.65% and 7.06%, respectively. The study used inverse probability weighting to balance measured baseline characteristics between treatment groups and a calibrated estimator to account for incomplete availability of baseline LDL-C; a prespecified sensitivity analysis that continued follow-up regardless of changes in background statin therapy produced consistent results.

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.^1,2 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’s Center for Observational Research
Amgen’s Center for Observational Research (CfOR) is a global, multidisciplinary organization dedicated to bringing epidemiologic and data science expertise together with real-world data (RWD) to generate evidence that advances Amgen’s mission to serve patients. Across the medicine lifecycle, CfOR helps deepen understanding of disease and how care is delivered in clinical practice, evaluate the comparative effectiveness and safety of Amgen’s medicines, and accelerate the development of innovative therapies. By paving the way for groundbreaking applications of RWD and real-world evidence (RWE), CfOR is helping progress the science that informs healthcare decision-making and deliver meaningful benefit for patients and the broader healthcare community. 

About Repatha
Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.

Repatha is one of the most extensively studied PCSK9 inhibitors, with clinical and real-world evidence across diverse populations and CV risk profiles.² The clinical benefits and safety of Repatha have been studied for 15 years in 51 clinical trials with over 57,000 patients.³ Repatha is the only PCSK9 inhibitor to demonstrate a significant reduction of cardiovascular events as both high-risk primary and secondary prevention, with patients achieving and maintaining dramatic LDL-C reductions using Repatha once every two weeks.^4,5

Repatha was first approved in 2015 and has since been used by approximately 9 million patients globally.⁶ In August 2025, the U.S. Food and Drug Administration broadened the approved use of Repatha to include adults at increased risk for major adverse CV events due to uncontrolled LDL-C. In August 2026, the European Commission approved an expanded indication for the use of Repatha in adults with established or high risk for ASCVD to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors, based on results from the Phase 3 VESALIUS-CV trial. Repatha is approved in 75 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union.⁷ Applications in other countries are pending. Repatha is the most covered PCSK9 inhibitor monoclonal antibody in the U.S.⁸ ~96% of patients are covered for Repatha across insurance types, with most patients paying less than $50/month.⁹ Through AmgenNow™, a direct-to-patient program, Repatha is available to patients at nearly 60% below the monthly list price.

INDICATIONS

Repatha^® is indicated:

• To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, coronary revascularization, or any ischemia-driven arterial revascularization) in adults at increased risk for these events.
• As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in:
  • adults with hypercholesterolemia.
  • adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
  • adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).

The safety and effectiveness of Repatha^® have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hypercholesterolemia.

IMPORTANT SAFETY INFORMATION

• Contraindication: Repatha^® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha^®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha^®.
• Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha^®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha^®, treat according to the standard of care, and monitor until signs and symptoms resolve.
• Adverse Reactions in Adults with Hypercholesterolemia: The most common adverse reactions (>5% of patients treated with Repatha^® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

  From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha^®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha^®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha^® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

• Adverse Reactions in the FOURIER Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha^® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha^®, 8.2% placebo), nasopharyngitis (7.8% Repatha^®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha^®, 4.8% placebo).

  Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha^® compared with 7.7% in patients that received placebo.

• Adverse Reactions in the VESALIUS Cardiovascular Outcomes Trial: The safety profile of Repatha^® in this trial was consistent with the known safety profile of Repatha^®.
• Adverse Reactions in Pediatric Patients with HeFH: The most common adverse reactions (>5% of patients treated with Repatha^® and more frequently than placebo) were: nasopharyngitis, headache, oropharyngeal pain, influenza, and upper respiratory tract infection.
• Adverse Reactions in Adults and Pediatric Patients with HoFH: In a 12-week study in 49 patients, the adverse reactions that occurred in at least two patients treated with Repatha^® and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis. In an open-label extension study in 106 patients, including 14 pediatric patients, no new adverse reactions were observed.
• Immunogenicity: Repatha^® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha^®.

Please see full Prescribing Information.

About Amgen 
Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world’s toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.

More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions.

Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average^®, and it is also part of the Nasdaq-100 Index^®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads.

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 BeOne Medicines Ltd.), the performance of Otezla^® (apremilast), our acquisitions of ChemoCentryx, Inc., Dark Blue Therapeutics, Ltd. 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 our 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 our 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 we project. 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 us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop 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 we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our 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 our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our 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, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our 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 our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our 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 we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

CONTACT: Amgen, Thousand Oaks 
Brianna Wilkins, 513-284-9807 (media)
Elissa Snook, 609-251-1407 (media)
Casey Capparelli, 805-447-1746 (investors)

REFERENCES

1. Vasan RS, Enserro DM, Xanthakis V, Beiser AS, Seshadri S. Temporal trends in the remaining lifetime risk of cardiovascular disease among middle-aged adults across 6 decades: the Framingham Study. Circulation. 2022:145(17):1324-1338. https://doi.org/10.1161/CIRCULATIONAHA.121.057889
2. Tsimikas S, Marcovina S. Ancestry, lipoprotein(a), and cardiovascular risk thresholds: JACC Review Topic of the Week. JACC. 2022;80(9):934-946. https://doi.org/10.1016/j.jacc.2022.06.019
3. Data on File; Amgen, 2025.
4. Ndumele CE, Blumenthal RS. VESALIUS and the anatomy of high-risk prevention. N Engl J Med. 2026;394(2):191-193. doi: 10.1056/NEJMe2515447
5. Marston NA, Bohula EA, Bhatia AK, et al. Evolocumab to reduce first major cardiovascular events in patients without known significant atherosclerosis and with diabetes: Results from the VESALIUS‑CV trial. JAMA. 2026;335(16):1400-1407. doi: 10.1001/jama.2026.3277
6. Data on File; Amgen, 2026.
7. Data on File; Amgen, 2025.
8. Data on File; Amgen, 2026.
9. Data on File; Amgen, 2026.

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SOURCE Amgen