REPATHA® CUTS RISK OF FIRST MAJOR CARDIOVASCULAR EVENTS BY 31% IN HIGH-RISK PATIENTS WITHOUT KNOWN SIGNIFICANT ATHEROSCLEROSIS

Repatha is the Solely PCSK9 Inhibitor to Considerably Scale back the Danger of First CV Occasions in Excessive-Danger Major Prevention

VESALIUS-CV Subgroup Findings Reinforce Advantage of Earlier Initiation of Repatha in Excessive-Danger Sufferers, with Median 44 mg/dL LDL-C Achieved

THOUSAND OAKS, Calif., March 28, 2026 /PRNewswire/ — Amgen (NASDAQ:AMGN) introduced right this moment that Repatha^® (evolocumab), when added to statins or different low-density lipoprotein ldl cholesterol (LDL-C)-lowering remedies, lowered the chance of first main hostile cardiovascular (CV) occasions (MACE) in high-risk main prevention sufferers with out recognized vital atherosclerosis (buildup of plaque within the arteries) and with diabetes. The findings had been introduced in a late-breaking session on the American School of Cardiology (ACC) seventy fifth Annual Scientific Session and concurrently revealed in the Journal of the American Medical Affiliation.

The outcomes are from a brand new subgroup evaluation of three,655 sufferers at elevated danger of CV occasions with out recognized vital atherosclerosis (all of whom had diabetes) adopted for a median of 4.8 years from the Part 3 VESALIUS-CV scientific trial. Outcomes confirmed Repatha lowered the chance of the composite main endpoint of coronary coronary heart illness (CHD) dying, myocardial infarction or ischemic stroke (3‑P MACE) by 31% in contrast with placebo. Repatha additionally lowered the chance of a twin composite main endpoint that included ischemia‑pushed revascularization (4‑P MACE) by 31%. The median achieved LDL-C was 44 mg/dL at 96 weeks within the Repatha added to optimized lipid-lowering remedy arm in comparison with 105 mg/dL within the placebo plus optimized lipid-lowering remedy arm (548 sufferers within the subgroup had been a part of a lipid sub-study).

“The proof is unequivocal: Intensive LDL-C reducing with Repatha considerably reduces the chance of main CV occasions for high-risk sufferers,” mentioned Jay Bradner, M.D., government vice chairman of Analysis and Growth at Amgen. “The brand new ACC/AHA Multisociety Guideline on the Administration of Dyslipidemia reinforces the significance of earlier, extra intensive reducing of LDL-C to stop CV occasions. VESALIUS-CV builds on this, exhibiting that in high-risk sufferers with out prior coronary heart assault or stroke, reducing LDL-C past what is often achieved right this moment can meaningfully cut back danger earlier than ASCVD takes maintain. These information additionally present the good thing about reducing LDL-C beneath 45 mg/dL with Repatha, a stage that is probably not achieved with statins or ezetimibe alone. Now’s the time to deal with earlier and assist all applicable sufferers attain decrease LDL-C objectives.”

Throughout secondary endpoints, Repatha demonstrated constant profit, together with the next composite endpoints: coronary heart assault, ischemic stroke or any ischemia-driven revascularization; CHD dying, coronary heart assault or revascularization; CV dying, coronary heart assault or ischemic stroke. Amongst particular person secondary endpoints, Repatha confirmed numerical reductions within the danger of coronary heart assault by 31%, ischemia-driven revascularization by 34% and ischemic stroke by 33%. Repatha demonstrated numerical traits for lowered mortality charges, together with CV dying (32% relative danger discount), CHD dying (27% relative danger discount) and all‑trigger dying (24% relative danger discount).

“This evaluation clearly demonstrates that the CV advantage of evolocumab within the VESALIUS-CV research contains those that had no recognized ASCVD, or vital plaque buildup within the arteries,” mentioned Nicholas Marston, M.D., M.P.H., assistant professor of medication, member of the TIMI Research Group and heart specialist at Brigham and Ladies’s Hospital and Harvard Medical College. “Decreasing LDL-C earlier with extra intensive remedy in high-risk main prevention sufferers, earlier than plaque turns into superior, can forestall the scientific onset of coronary heart illness. These findings verify the substantial danger discount that may be achieved by treating extra proactively with evolocumab fairly than ready for the event of serious atherosclerosis or a CV occasion to then intensify lipid-lowering remedy.”

For extra data on Amgen abstracts and presentation occasions on the ACC seventy fifth Annual Scientific Session, see beneath.

• Evolocumab for the Discount of First Main Cardiovascular Occasions in Sufferers with out Vital Atherosclerosis: Outcomes from VESALIUS-CV
  LBS.105, Saturday, March 28 from 4:00 – 4:10 p.m. CST
• LDL-C Decreasing and Related Danger Discount of Myocardial Infarction and Stroke-Associated Hospitalizations in Sufferers with ASCVD and Diabetes
  Summary #1165-11, Monday, March 30 from 10:18 – 10:25 a.m. CST

Heart problems (CVD) is the main explanation for dying worldwide, and most CV occasions happen in individuals with no prior historical past of coronary heart assault or stroke.¹ Excessive LDL-C is among the most modifiable danger components for coronary heart assault and stroke, and extended publicity to elevated LDL‑C will increase CV danger over time, making earlier and extra intensive LDL‑C reducing vital to decreasing the chance of a primary CV occasion.^2,3,4

Repatha was first authorized in 2015 and has since been utilized by greater than 8 million sufferers globally.^5,6 In August 2025, the U.S. Meals and Drug Administration broadened the authorized use of Repatha to incorporate adults at elevated danger for main hostile CV occasions as a consequence of uncontrolled LDL-C.

Concerning the VESALIUS-CV Trial
VESALIUS-CV is a Part 3, double-blind, randomized, placebo-controlled, international scientific trial designed to guage the impression of LDL-C reducing with evolocumab on MACE in adults at excessive CV danger with out prior coronary heart assault or stroke. Outcomes had been revealed within the New England Journal of Drugs in November 2025. Repatha demonstrated a 25% relative discount within the danger of a composite of coronary coronary heart illness (CHD) dying, coronary heart assault or ischemic stroke (3-P MACE), and 19% discount in a broader composite that additionally included any ischemia-driven arterial revascularization (4-P MACE). Repatha additionally lowered the chance of coronary heart assault by 36%.

VESALIUS-CV enrolled greater than 12,000 sufferers with recognized ASCVD or high-risk diabetes, who had no historical past of coronary heart assault or stroke, an LDL-C ≥ 90 mg/dL, or non-high-density lipoprotein ldl cholesterol (non-HDL-C) ≥ 120 mg/dL, or apolipoprotein B ≥ 80 mg/dL; and handled with highest tolerated dose of statin and/or ezetimibe. The median baseline LDL-C was 122 mg/dL (IQR, 104-149 mg/dL) on native lab testing. Members had been randomized to obtain Repatha or placebo along with optimized lipid-lowering remedy and had been adopted for a median of roughly 4.6 years.

Amgen’s Dedication to Cardiovascular Innovation
Heart problems (CVD) stays a significant international well being menace, linked to a number of interrelated danger components like excessive LDL-C, Lp(a), weight problems, diabetes and hypertension.^7,8 These dangers typically coexist and require a complete method to prevention and care. Amgen is taking daring motion, constructing on many years of management in CVD by LDL-C administration to advance extra progressive, investigational remedies within the pipeline concentrating on widespread drivers of CVD. By combining scientific innovation with strategic partnerships to drive earlier testing, higher care and broader entry, Amgen’s efforts replicate a sustained dedication to advancing each the science and the system of CV care.

About Repatha
Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin kind 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), stopping PCSK9-mediated LDLR degradation and allowing LDLR to recycle again to the liver cell floor. By inhibiting the binding of PCSK9 to LDLR, Repatha will increase the variety of LDLRs out there to clear LDL from the blood, thereby reducing LDL-C ranges.

Repatha is among the most extensively studied PCSK9 inhibitors, with scientific and real-world proof throughout numerous populations and CV danger profiles.⁸ The scientific advantages and security of Repatha have been studied for 15 years in 51 scientific trials with over 57,000 sufferers.⁹ Repatha is the one PCSK9 inhibitor to show a big discount of cardiovascular occasions as each high-risk main and secondary prevention. Repatha has been prescribed to over 8 million sufferers globally and is authorized in 74 nations, together with the U.S., Japan, Canada and in all 28 nations which might be members of the European Union.⁹ Functions in different nations are pending.

INDICATIONS
 Repatha^® is a PCSK9 (proprotein convertase subtilisin/kexin kind 9) inhibitor indicated:

• To scale back the chance of main hostile cardiovascular (CV) occasions (CV dying, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at elevated danger for these occasions.
• As an adjunct to weight loss program and train to cut back low-density lipoprotein ldl cholesterol (LDL-C) in:
• adults with hypercholesterolemia.
• adults and pediatric sufferers aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
• adults and pediatric sufferers aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).

The protection and effectiveness of Repatha^® haven’t been established in pediatric sufferers with HeFH or HoFH who’re youthful than 10 years previous or in pediatric sufferers with different forms of hypercholesterolemia. For full prescribing data, go to www.Repatha.com.

 IMPORTANT SAFETY INFORMATION   

• Contraindication: Repatha^® is contraindicated in sufferers with a historical past of a critical hypersensitivity response to evolocumab or any of the excipients in Repatha^®. Critical hypersensitivity reactions together with angioedema have occurred in sufferers handled with Repatha^®.
• Hypersensitivity Reactions: Hypersensitivity reactions, together with angioedema, have been reported in sufferers handled with Repatha^®. If indicators or signs of great hypersensitivity reactions happen, discontinue remedy with Repatha^®, deal with based on the usual of care, and monitor till indicators and signs resolve.
• Antagonistic Reactions in Adults with Major Hypercholesterolemia: The most typical hostile reactions (>5% of sufferers handled with Repatha^® and extra regularly than placebo) had been: nasopharyngitis, higher respiratory tract an infection, influenza, again ache, and injection website reactions.

  From a pool of the 52-week trial and 7 12-week trials: Native injection website reactions occurred in 3.2% and three.0% of Repatha^®-treated and placebo-treated sufferers, respectively. The most typical injection website reactions had been erythema, ache, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha^®-handled and placebo-treated sufferers, respectively. The most typical hypersensitivity reactions had been 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%). 

• Antagonistic Reactions within the FOURIER Cardiovascular Outcomes Trial: The most typical hostile reactions (>5% of sufferers handled with Repatha^® and extra regularly than placebo) had been: diabetes mellitus (8.8% Repatha^®, 8.2% placebo), nasopharyngitis (7.8% Repatha^®, 7.4% placebo), and higher respiratory tract an infection (5.1% Repatha^®, 4.8% placebo).

  Among the many 16,676 sufferers with out diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus through the trial was 8.1% in sufferers handled with Repatha^® in contrast with 7.7% in sufferers that acquired placebo. 

• Antagonistic Reactions in Pediatric Sufferers with HeFH: The most typical hostile reactions (>5% of sufferers handled with Repatha^® and extra regularly than placebo) had been: nasopharyngitis, headache, oropharyngeal ache, influenza, and higher respiratory tract an infection.
• Antagonistic Reactions in Adults and Pediatric Sufferers with HoFH: In a 12-week research in 49 sufferers, the hostile reactions that occurred in a minimum of two sufferers handled with Repatha^® and extra regularly than placebo had been: higher respiratory tract an infection, influenza, gastroenteritis, and nasopharyngitis. In an open-label extension research in 106 sufferers, together with 14 pediatric sufferers, no new hostile reactions had been noticed.
• Immunogenicity: Repatha^® is a human monoclonal antibody. As with all therapeutic proteins, there’s potential for immunogenicity with Repatha^®.

Please see full Prescribing Data. 

About Amgen 
Amgen discovers, develops, manufactures and delivers progressive medicines to struggle a few of the world’s hardest illnesses. Harnessing the most effective of biology and know-how, Amgen reaches tens of millions of sufferers with its medicines.

Greater than 45 years in the past, Amgen helped set up the biotechnology trade at its U.S. headquarters in Thousand Oaks, California, and it stays on the slicing fringe of innovation, utilizing know-how and human genetic information to push past what is understood right this moment. Amgen is advancing a broad and deep pipeline and portfolio of medicines to deal with most cancers, coronary heart illness, inflammatory situations, uncommon illnesses and weight problems and obesity-related situations.

Amgen has been constantly acknowledged for innovation and office tradition, together with honors from Quick Firm and Forbes. Amgen is among the 30 corporations that comprise the Dow Jones Industrial Common^®, and additionally it is a part of the Nasdaq-100 Index^®, which incorporates the most important and most progressive non-financial corporations listed on the Nasdaq Inventory Market based mostly on market capitalization.

For extra data, go to Amgen.com and observe Amgen on X, LinkedIn, Instagram, YouTube, Fb, TikTok and Threads.

Amgen Ahead-Wanting Statements
This information launch incorporates forward-looking statements which might be based mostly on the present expectations and beliefs of Amgen. All statements, apart from statements of historic reality, are statements that may very well be deemed forward-looking statements, together with any statements on the result, advantages and synergies of collaborations, or potential collaborations, with some other firm (together with BeOne Medicines Ltd. or Kyowa Kirin Co., Ltd.), the efficiency of Otezla^® (apremilast), our acquisitions of ChemoCentryx, Inc., Darkish Blue Therapeutics, Ltd. or Horizon Therapeutics plc (together with the possible efficiency and outlook of Horizon’s enterprise, efficiency and alternatives, and any potential strategic advantages, synergies or alternatives anticipated on account of such acquisition), in addition to estimates of revenues, working margins, capital expenditures, money, different monetary metrics, anticipated authorized, arbitration, political, regulatory or scientific outcomes or practices, buyer and prescriber patterns or practices, reimbursement actions and outcomes, results of pandemics or different widespread well being issues on our enterprise, outcomes, progress, and different such estimates and outcomes. Ahead-looking statements contain vital dangers and uncertainties, together with these mentioned beneath and extra absolutely described within the Securities and Alternate Fee reviews filed by Amgen, together with our most up-to-date annual report on Kind 10-Okay and any subsequent periodic reviews on Kind 10-Q and present reviews on Kind 8-Okay. Until in any other case famous, Amgen is offering this data as of the date of this information launch and doesn’t undertake any obligation to replace any forward-looking statements contained on this doc on account of new data, future occasions or in any other case.

No forward-looking assertion could be assured and precise outcomes might differ materially from these we undertaking. Discovery or identification of latest product candidates or growth of latest indications for present merchandise can’t be assured and motion from idea to product is unsure; consequently, there could be no assure that any explicit product candidate or growth of a brand new indication for an present product can be profitable and grow to be a business product. Additional, preclinical outcomes don’t assure protected and efficient efficiency of product candidates in people. The complexity of the human physique can’t be completely, or typically, even adequately modeled by laptop or cell tradition programs or animal fashions. The size of time that it takes for us to finish scientific trials and procure regulatory approval for product advertising has previously assorted and we anticipate related variability sooner or later. Even when scientific trials are profitable, regulatory authorities might query the sufficiency for approval of the trial endpoints we’ve got chosen. We develop product candidates internally and thru licensing collaborations, partnerships and joint ventures. Product candidates which might be derived from relationships could also be topic to disputes between the events or might show to be not as efficient or as protected as we might have believed on the time of coming into into such relationship. Additionally, we or others may establish security, negative effects or manufacturing issues with our merchandise, together with our units, after they’re in the marketplace.

Our outcomes could also be affected by our skill to efficiently market each new and present merchandise domestically and internationally, scientific and regulatory developments involving present and future merchandise, gross sales progress of not too long ago launched merchandise, competitors from different merchandise together with biosimilars, difficulties or delays in manufacturing our merchandise and international financial situations, together with these ensuing from geopolitical relations and authorities actions. As well as, gross sales of our merchandise are affected by pricing stress, political and public scrutiny and reimbursement insurance policies imposed by third-party payers, together with governments, non-public insurance policy and managed care suppliers and could also be affected by regulatory, scientific and guideline developments and home and worldwide traits towards managed care and healthcare price containment. Moreover, our analysis, testing, pricing, advertising and different operations are topic to intensive regulation by home and overseas authorities regulatory authorities. Our enterprise could also be impacted by authorities investigations, litigation and product legal responsibility claims. As well as, our enterprise could also be impacted by the adoption of latest tax laws or publicity to extra tax liabilities. Additional, whereas we routinely receive patents for our merchandise and know-how, the safety provided by our patents and patent functions could also be challenged, invalidated or circumvented by our opponents, or we might fail to prevail in current and future mental property litigation. We carry out a considerable quantity of our business manufacturing actions at a couple of key amenities, together with in Puerto Rico, and likewise rely on third events for a portion of our manufacturing actions, and limits on provide might constrain gross sales of sure of our present merchandise and product candidate growth. An outbreak of illness or related public well being menace, and the general public and governmental effort to mitigate in opposition to the unfold of such illness, may have a big hostile impact on the availability of supplies for our manufacturing actions, the distribution of our merchandise, the commercialization of our product candidates, and our scientific trial operations, and any such occasions might have a fabric hostile impact on our product growth, product gross sales, enterprise and outcomes of operations. We depend on collaborations with third events for the event of a few of our product candidates and for the commercialization and gross sales of a few of our business merchandise. As well as, we compete with different corporations with respect to lots of our marketed merchandise in addition to for the invention and growth of latest merchandise. Additional, some uncooked supplies, medical units and part elements for our merchandise are provided by sole third-party suppliers. Sure of our distributors, clients and payers have substantial buying leverage of their dealings with us. The invention of serious issues with a product much like certainly one of our merchandise that implicate a whole class of merchandise may have a fabric hostile impact on gross sales of the affected merchandise and on our enterprise and outcomes of operations. Our efforts to collaborate with or purchase different corporations, merchandise or know-how, and to combine the operations of corporations or to assist the merchandise or know-how we’ve got acquired, is probably not profitable, and should lead to unanticipated prices, delays or failures to understand the advantages of the transactions. A breakdown, cyberattack or data safety breach of our data know-how programs may compromise the confidentiality, integrity and availability of our programs and our information. Our inventory value is unstable and could also be affected by quite a few occasions. Our enterprise and operations could also be negatively affected by the failure, or perceived failure, of attaining our sustainability targets. The results of world local weather change and associated pure disasters may negatively have an effect on our enterprise and operations. World financial situations might amplify sure dangers that have an effect on our enterprise. Our enterprise efficiency may have an effect on or restrict the flexibility of our Board of Administrators to declare a dividend or our skill to pay a dividend or repurchase our widespread inventory. We might not be capable of entry the capital and credit score markets on phrases which might be favorable to us, or in any respect.

CONTACT: Amgen, Thousand Oaks
Madison Howard, 773-636-4910 (media)
Elissa Snook, 609-251-1407 (media)
Casey Capparelli, 805-447-1746 (traders) 

REFERENCES

1. Martin SS, Aday AW, Allen NB, et al. American Coronary heart Affiliation Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Committee. 2025 Coronary heart Illness and Stroke Statistics: A Report of US and World Knowledge From the American Coronary heart Affiliation. Circulation. 2025151(8)le41–e660. https://doi.org/10.1161/CIR.0000000000001303
2. Jurin I, et al. Outcomes of sufferers with regular LDL-cholesterol at admission for acute coronary syndromes: decrease shouldn’t be at all times higher. J Cardiovasc Dev Dis. 2024;11(4):120. https://doi.org/10.3390/jcdd11040120
3. Domanski MJ, Tian X, Wu CO, et al. Time course of LDL ldl cholesterol publicity and heart problems occasion danger. J Am Coll Cardiol. 2024;76(13):1507-1516.
4. Kalra DK, Ray KK, Bajaj A, et al.  Low-density lipoprotein ldl cholesterol reducing and danger of main hostile cardiovascular occasions in main prevention trials: A meta-analysis. J Clin Lipidol. 2026.
5. Shapiro MD. Extended and Pronounced Low-Density Lipoprotein Ldl cholesterol Decreasing: The Reward That Retains Giving. Circulation. 2022;146(15):1120-1122. 
6. Rao SV, O’Donoghue ML, Ruel M, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Administration of Sufferers With Acute Coronary Syndromes: A Report of the American School of Cardiology/American Coronary heart Affiliation Joint Committee on Scientific Apply Tips. Circulation. 2025;151(13):e771-e862.
7. Vasan RS, Enserro DM, Xanthakis V, Beiser AS, Seshadri S. Temporal traits within the remaining lifetime danger of heart problems amongst middle-aged adults throughout 6 many years: the Framingham Research. Circulation. 2022:145(17):1324-1338. https://doi.org/10.1161/CIRCULATIONAHA.121.057889
8. Tsimikas S, Marcovina S. Ancestry, lipoprotein(a), and cardiovascular danger thresholds: JACC Evaluate Subject of the Week. JACC. 2022;80(9):934-946. https://doi.org/10.1016/j.jacc.2022.06.019 MAC: REF-99099
9. Knowledge on File. Amgen, 2025.

SOURCE Amgen