NEW DATA AT AHA 2026 DEMONSTRATES THE VALUE OF TREATMENT WITH REPATHA® EARLIER IN THE CARDIOVASCULAR RISK CONTINUUM

Independent VESALIUS-CV Analysis Finds Repatha Highly Cost-Effective in High-Risk Patients Without a Prior Heart Attack or Stroke

Long-Term FOURIER External-Control Analysis Shows Repatha Associated With 29% Lower Risk of Major Cardiovascular Events in Patients Living With ASCVD

THOUSAND OAKS, Calif., Nov. 9, 2026 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced new data at the American Heart Association (AHA) Scientific Sessions 2026 that further strengthen the case for more intensive lowering of low-density lipoprotein cholesterol (LDL-C) with Repatha^® (evolocumab) in high-risk patients. The findings add to evidence supporting Repatha for people with and without a prior cardiovascular event.

New late-breaking findings show that Repatha was a highly cost-effective treatment option for high-risk patients without a prior heart attack or stroke. The first independent health economic analysis using detailed data from individual participants in the Phase 3 VESALIUS-CV trial compared treatment costs with projected health benefits. The analysis found Repatha to be cost-effective relative to those benefits at approximately 36% below the ACC/AHA benchmark. The Duke Clinical Research Institute led the analysis in collaboration with the TIMI Study Group at Mass General Brigham and Harvard.

Furthermore, a separate analysis found adding Repatha to standard therapy to be highly cost-effective versus standard therapy alone in adults living with atherosclerotic cardiovascular disease (ASCVD). Together, the analyses support Repatha's cost-effectiveness across a range of high-risk patient populations.

"In the U.S., every 40 seconds someone has a heart attack and three out of four of those are first-time events. With more than a decade of clinical research with Repatha and growing evidence supporting earlier LDL-C lowering, no one should have to wait for a first heart attack or stroke to take more aggressive action against cardiovascular risk," said Murdo Gordon, executive vice president of Global Markets and Policy at Amgen. "For high-risk patients with a guideline recommended LDL-C goal below 55 mg/dL, we need to help make reaching that goal sooner a reality. That means pairing strong clinical data with continued efforts to address barriers to care. We've taken actions to make Repatha more affordable and accessible, and these findings add to the evidence of its benefit to patients."

Additional Analyses Highlight LDL-C Lowering and Long-Term Cardiovascular Benefit

In addition to the cost-effectiveness study, Amgen presented multiple studies across its CV portfolio. Results include analyses that build on the landmark VESALIUS-CV and FOURIER studies, highlighting Repatha's CV benefit in primary prevention patients with chronic kidney disease (CKD) and with long-term follow-up in patients with ASCVD.

• A pre-specified VESALIUS-CV analysis showed that patients with CKD and no prior heart attack or stroke face substantially higher CV risk, with an approximately 90% higher rate of coronary heart disease death, heart attack or ischemic stroke (3-P major adverse cardiovascular events (MACE)), compared to patients without CKD. Over a median follow-up of 4.6 years, Repatha significantly reduced the risk of these events in people with CKD, lowering 3-P MACE rates by 39%, reducing 4-P MACE (3-P MACE plus ischemia-driven arterial revascularization) by 23%, and reducing the risk of all-cause death by 29%. The first-of-its-kind 2026 AHA/ACC/ADA/ASN Cardiovascular-Kidney-Metabolic Syndrome Guideline recognizes the elevated CV risk associated with CKD and emphasizes managing comorbid risk factors, including high LDL-C, to help reduce CV risk.¹
  
  
  
  
• A new analysis evaluated the long-term effectiveness of Repatha by comparing patients treated with Repatha in FOURIER and its open-label extension (OLE) with a non-randomized external control drawn from UK health records. Over a maximum follow-up of > 8 years, Repatha was associated with a 29% lower rate of 3-P MACE, a composite of heart attack, stroke or CV death, and a 25% lower risk of CV death, providing additional evidence that Repatha's CV benefits can be maintained beyond the randomized trial period.

For more information about the data presented at AHA, see below:

• VESALIUS-CV – Health Economic Outcomes in the Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke Randomized Trial
  
  Late-Breaking Science: FS.12: Featured Science Potpourri, Presented Monday, November 9
  
  
  
  
• T2T – Test 2 Treat: A Hybrid Effectiveness-Implementation Trial to Improve LDL-C Testing and Management After Hospitalization for Atherosclerotic Cardiovascular Disease
  
  Late-Breaking Science: FS.12: Featured Science Potpourri, Presented Monday, November 9
  
  
  
  
• Closing the Gap in Guideline-Directed Lipid Management Through a Scalable Clinician Education Initiative
  
  Abstract #MDP2364, Presented Monday, November 9
  
  
  
  
• Improving LDL-C Goal Attainment Through a Digital Health-Enabled Lipid Program: Early Experience from the LATTICE Consortium
  
  Abstract #Mo3067, Presented Monday, November 9
  
  
  
  
• Prevalence of Elevated Lipoprotein(a) Among U.S. Adults with Established Atherosclerotic Cardiovascular Disease
  
  Abstract #Mo3004, Presented Monday, November 9
  
  
  
  
• Evolocumab in Patients with Chronic Kidney Disease and Without a Prior MI or Stroke in VESALIUS-CV
  
  Abstract #14174, Presented Sunday, November 8
  
  
  
  
• Long-Term Effectiveness of Evolocumab in Reducing the Risk for Major Adverse Cardiovascular Events: Comparing FOURIER OLE Data to External Control Using a Principled Approach
  
  Abstract #6839, Presented Sunday, November 8
  
  
  
  
• Lipid Management Patterns and Low-Density Lipoprotein Cholesterol Goal Attainment Among Patients with High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke in the US Stratified by Race/Ethnicity
  
  Abstract #Sa3133, Presented Saturday, November 7
  
  
  
  
• Evolocumab for Stroke Prevention in Patients at High CV Risk Without a Prior Stroke or MI in VESALIUS-CV
  
  Abstract #MDP0854, Presented Saturday, November 7
  
  
  
  
• Real-World Persistence and Adherence Among Patients Initiating Glucagon-Like Peptide-1-Based Therapies with Established Atherosclerotic Cardiovascular Disease
  
  Abstract #Sa3085, Presented Saturday, November 7

About the VESALIUS-CV Trial

VESALIUS-CV is a Phase 3, double-blind, randomized, placebo-controlled, global clinical trial designed to evaluate the impact of LDL-C lowering with evolocumab on MACE in adults at high CV risk without prior heart attack or stroke. Results were published in the New England Journal of Medicine in November 2025. Repatha demonstrated a 25% relative reduction in the risk of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke (3-P MACE), and 19% reduction in a broader composite that also included any ischemia-driven arterial revascularization (4-P MACE). Repatha also reduced the risk of heart attack by 36%. In a lipid sub-study, adding Repatha to a maximally tolerated dose of statin and/or ezetimibe substantially lowered LDL-C levels among observed patients, with a median level of 45 mg/dL compared to 109 mg/dL in the placebo group.

VESALIUS-CV enrolled more than 12,000 patients with known ASCVD or high-risk diabetes, who had no history of heart attack or stroke, an LDL-C ≥ 90 mg/dL, or non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 120 mg/dL, or apolipoprotein B ≥ 80 mg/dL; and treated with highest tolerated dose of statin and/or ezetimibe. The median baseline LDL-C was 122 mg/dL (IQR, 104-149 mg/dL). Participants were randomized to receive Repatha or placebo in addition to optimized lipid-lowering therapy and were followed for a median of approximately 4.6 years.

About the FOURIER Trial 

FOURIER was a Phase 3, double-blind, randomized, placebo-controlled, global clinical trial designed to evaluate the impact of LDL-C lowering with Repatha (evolocumab) on MACE in adults with established atherosclerotic cardiovascular disease.

FOURIER enrolled more than 27,000 patients with known ASCVD (history of myocardial infarction, nonhemorrhagic stroke or symptomatic peripheral artery disease) and LDL-C ≥70 mg/dL and/or non-HDL-C ≥100 mg/dL, despite high- or moderate-intensity statin therapy.

In the trial, Repatha reduced LDL-C levels by 59%, from a median baseline value of 92 mg/dL to 30 mg/dL (P<0.001). Repatha also significantly reduced the risk of major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or coronary revascularization (0.85; 95% CI, 0.79-0.92; P<0.001) by 15% and the composite of cardiovascular death, myocardial infarction or stroke (0.80; 95% CI, 0.73-0.88; P<0.001) by 20%. The results were consistent across key subgroups, including the subgroup of patients in the lowest quartile for baseline LDL-C levels (median, 74 mg/dL).

About the FOURIER-OLE Trial 

FOURIER-OLE was the multicenter, open label extension (OLE) study designed to assess the long-term safety of Repatha (evolocumab) in subjects (adults with clinically evident ASCVD) who completed the Phase 3 FOURIER cardiovascular outcomes trial.

The OLE enrolled over 6,600 patients across Europe and the United States who received Repatha for approximately 5 years, with some patients receiving Repatha for up to 8.4 years in aggregate across the FOURIER and OLE studies. Medically significant and sustained reduction in LDL-C levels were observed, with more than 85% of patients achieving an LDL-C level of <40 mg/dL during the OLE period. No new long-term safety findings were observed. FOURIER-OLE is the longest trial of PCSK9i monoclonal antibody (mAb) to date.

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.

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.⁴ The clinical benefits and safety of Repatha have been studied for 15 years in 51 clinical trials with over 57,000 patients.⁵ 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.^6,7

Repatha was first approved in 2015 and has since been used by approximately 9 million patients globally.⁸ 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.⁹ Applications in other countries are pending. Repatha is the most covered PCSK9 inhibitor monoclonal antibody in the U.S.⁹ ~96% of patients are covered for Repatha across insurance types, with most patients paying less than $50/month.¹⁰ 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)

Casey Capparelli, 805-447-1746 (investors)

REFERENCES

1. Writing Committee Members; Ndumele CE, Rodriguez F, Dixon DL, et al. 2026 AHA/ACC/ADA/ASN guideline for the prevention, detection, evaluation, and management of cardiovascular-kidney-metabolic syndrome: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2026;154(4):e50-e158. https://doi.org/10.1161/CIR.0000000000001453
2. 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
3. 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
4. Data on File; Amgen, 2025.
5. Ndumele CE, Blumenthal RS. VESALIUS and the Anatomy of High-Risk Prevention. N Engl J Med.2026;394(2):191-193. https://doi.org/10.1056/nejme2515447
6. 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. https://doi.org/10.1001/jama.2026.3277
7. Data on File; Amgen, 2026.
8. Data on File; Amgen, 2025.
9. Data on File; Amgen, 2026.
10. Data on File; Amgen, 2026.

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