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THOUSAND OAKS, Calif., Nov. 16, 2019 /PRNewswire/ — Amgen today appear a new assay from the Repatha® (evolocumab) cardiovascular outcomes (FOURIER) abstraction that evaluates the capability of Repatha in patients who accept suffered a contempo myocardial infarction (MI). The assay showed that patients who accomplished a contempo MI (less than one year) were at college accident of consecutive cardiovascular (CV) contest compared to patients who had an MI over a year ago. In the analysis, the accident abridgement for experiencing a affection attack, achievement or CV death, in Repatha-treated patients advised within one year column MI was 25% compared to 15% in those patients with a added abroad MI. The after-effects will be presented at the American Affection Association Anniversary Accurate Sessions in Philadelphia on Monday, Nov. 18.



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“Nearly 1 in 5 patients will accept a alternate CV accident during the aboriginal year afterwards a affection beforehand which makes that year a analytical time for high-risk patients1,” said Robert Giugliano, M.D., FOURIER controlling board affiliate and a arch investigator at the TIMI Abstraction Group at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School. “These after-effects authenticate the accent of accelerated lipid-lowering assay in the aboriginal year afterward a affection beforehand and accommodate added affirmation that evolocumab decidedly reduces CV accident and improves outcomes for high-risk patients.”

In this assay of the battleground FOURIER outcomes study, 5,711 patients who accomplished an MI aural one to 12 months of randomization were compared to 16,609 patients with a added abroad accident (>12 months above-mentioned to randomization) to appraise the adeptness of Repatha on the primary endpoint (CV death, MI, stroke, ambiguous angina or coronary revascularization) and the key accessory endpoint (CV death, MI or stroke).



“Far too abounding patients abide at accident of accession CV accident because they are not managing one of the best important adjustable accident factors for a affection attack: aerial LDL-C2,” said Darryl Sleep, M.D., arch carnality admiral of All-around Medical and arch medical administrator at Amgen. “These abstracts authenticate the important role cardiologists comedy in carefully ecology and managing LDL-C in high-risk patients, and abutment contempo able guideline recommendations that alarm for added accelerated abridgement of LDL-C to lower the accident of approaching CV contest in high-risk patients3,4.”



New FOURIER Abstracts Shows No Appulse on Patient-Reported Acknowledgment Action
An added assay from the FOURIER abstraction presented at AHA reinforces the assurance and adeptness of accelerated LDL-C blurred with Repatha in high-risk cardiovascular ache (CVD) patients. The assay evaluated the appulse of blurred LDL-C with Repatha on acknowledgment as appear by patients with abiding CVD and begin that the accession of Repatha to statin assay had no appulse on appear accustomed acknowledgment function, including in those with absolute low LDL-C levels.

PROFICIO Affairs
FOURIER is allotment of Amgen’s PROFICIO (Program to Reduce LDL-C and cardiovascular Outcomes Afterward Inhibition of PCSK9 In altered pOpulations) affairs of analytic studies investigating the appulse of Repatha on LDL-C and CVD beyond assorted populations at aerial CV risk, including those managed by statins, statin-intolerant patients, those with abiogenetic disorders and patients with atherosclerosis. To date, the PROFICIO affairs consists of 36 trials including added than 38,000 patients worldwide.

Repatha Cardiovascular Outcomes (FOURIER) Abstraction Design
FOURIER (Further cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a bunch Phase 3 randomized, double-blind, placebo-controlled trial, was advised to appraise whether analysis with Repatha in aggregate with statin assay compared to placebo added statin assay reduces cardiovascular events. The primary endpoint was the time to cardiovascular death, myocardial infarction, stroke, analysis for ambiguous angina, or coronary revascularization. The key accessory endpoint was the time to cardiovascular death, myocardial infarction or stroke. 

Eligible patients with aerial cholesterol (LDL-C ≥70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL) and clinically axiomatic atherosclerotic cardiovascular ache at added than 1,300 abstraction locations about the apple were randomized to accept Repatha subcutaneous 140 mg every two weeks or 420 mg account added able statin dose; or placebo subcutaneous every two weeks or account added able statin dose. Optimized statin assay was authentic as at atomic atorvastatin 20 mg or agnate circadian with a advocacy for at atomic atorvastatin 40 mg or agnate circadian area approved. The abstraction was event-driven and connected until at atomic 1,630 patients accomplished a key accessory endpoint.

About Repatha® (evolocumab)
Repatha is a beastly monoclonal antibiotic that inhibits proprotein convertase subtilisin/kexin blazon 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from bounden to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR abasement and allowing LDLR to recycle aback to the alarmist corpuscle surface. By inhibiting the bounden of PCSK9 to LDLR, Repatha increases the cardinal of LDLRs accessible to bright LDL from the blood, thereby blurred LDL-C levels.5

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Repatha is accustomed in added than 70 countries, including the U.S., Japan, Canada and in all 28 countries that are associates of the European Union. Applications in added countries are pending.

Important U.S. Artefact Advice
Repatha is a PCSK9 (proprotein convertase subtilisin/kexin blazon 9) inhibitor antibiotic indicated:

The assurance and capability of Repatha have not been accustomed in pediatric patients with HoFH who are adolescent than 13 years old or in pediatric patients with primary hyperlipidemia or HeFH.

Important U.S. Assurance Advice
Contraindication: Repatha is contraindicated in patients with a history of a austere hypersensitivity acknowledgment to Repatha. Austere hypersensitivity reactions including angioedema accept occurred in patients advised with Repatha.

Allergic reactions: Hypersensitivity reactions (e.g. angioedema, rash, urticaria) accept been appear in patients advised with Repatha, including some that led to cessation of therapy. If signs or affection of austere allergic reactions occur, abandon analysis with Repatha, amusement according to the accepted of care, and adviser until signs and affection resolve.

Adverse reactions: The best accepted adverse reactions (>5% of patients advised with Repatha and occurring added frequently than placebo) were: nasopharyngitis, aerial respiratory amplitude infection, influenza, aback pain, and bang armpit reactions. 

From a basin of the 52-week balloon and seven 12-week trials: Local bang armpit reactions occurred in 3.2% and 3.0% of Repatha-treated and placebo-treated patients, respectively. The best accepted bang armpit reactions were erythema, pain, and bruising.

Allergic reactions occurred in 5.1% and 4.7% of Repatha-treated and placebo-treated patients, respectively. The best accepted allergic reactions were adventurous (1.0% against 0.5% for Repatha and placebo, respectively), eczema (0.4% against 0.2%), erythema (0.4% against 0.2%), and urticaria (0.4% against 0.1%).

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The best accepted adverse reactions in the Cardiovascular Outcomes Balloon (>5% of patients advised with Repatha and occurring added frequently than placebo) were: diabetes mellitus (8.8% Repatha, 8.2% placebo), nasopharyngitis (7.8% Repatha, 7.4% placebo), and aerial respiratory amplitude infection (5.1% Repatha, 4.8% placebo).   

Among the 16,676 patients afterwards diabetes mellitus at baseline, the accident of new-onset diabetes mellitus during the balloon was 8.1% in patients assigned to Repatha compared with 7.7% in those assigned to placebo.  

Homozygous Familial Hypercholesterolemia (HoFH): The adverse reactions that occurred in at atomic two patients advised with Repatha and added frequently than placebo were: aerial respiratory amplitude infection, influenza, gastroenteritis, and nasopharyngitis.

Immunogenicity: Repatha is a beastly monoclonal antibody. As with all ameliorative proteins, there is a abeyant for immunogenicity with Repatha. 

Please acquaintance Amgen Medinfo at 800-77-AMGEN (800-772-6436) or 844-REPATHA (844-737-2842) apropos Repatha® availability or accession added information, including full  Prescribing Information, Media the Cardiovascular Ameliorative Area
Building on added than three decades of acquaintance in developing biotechnology medicines for patients with austere illnesses, Amgen is committed to acclamation important accurate questions to beforehand affliction and advance the lives of patients with cardiovascular disease, the arch account of anguish and bloodshed worldwide.6 Amgen’s research into cardiovascular disease, and abeyant analysis options, is allotment of a growing adequacy at Amgen that utilizes beastly analysis to analyze and validate assertive biologic targets. Through its own analysis and development efforts, as able-bodied as partnerships, Amgen is architecture a able-bodied cardiovascular portfolio consisting of several accustomed and investigational molecules in an accomplishment to abode a cardinal of today’s important unmet accommodating needs, such as aerial cholesterol and affection failure.

About Amgen
Amgen is committed to unlocking the abeyant of analysis for patients adversity from austere illnesses by discovering, developing, accomplishment and carrying avant-garde beastly therapeutics. This admission begins by application accoutrement like avant-garde beastly analysis to break the complexities of ache and accept the fundamentals of beastly biology.

Amgen focuses on areas of aerial unmet medical charge and leverages its biologics accomplishment adeptness to strive for solutions that advance bloom outcomes and badly advance people’s lives. A biotechnology avant-garde back 1980, Amgen has developed to be the world’s better absolute biotechnology company, has accomplished millions of patients about the apple and is developing a activity of medicines with breakaway potential. 

For added information, appointment Media chase us on Media

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Forward-Looking Statements 
This account absolution contains advanced statements that are based on the accepted expectations and behavior of Amgen. All statements, added than statements of absolute fact, are statements that could be accounted advanced statements, including any statements on the outcome, allowances and synergies of accord with any added company, including BeiGene, Ltd., or the accession of Otezla® (apremilast), including advancing Otezla sales advance and the timing of non-GAAP EPS accretion, as able-bodied as estimates of revenues, operating margins, basic expenditures, cash, added banking metrics, accepted legal, arbitration, political, authoritative or analytic after-effects or practices, chump and prescriber patterns or practices, acceding activities and outcomes and added such estimates and results. Advanced statements absorb cogent risks and uncertainties, including those discussed beneath and added absolutely declared in the Securities and Exchange Commission letters filed by Amgen, including our best contempo anniversary address on Form 10-K and any consecutive alternate letters on Form 10-Q and accepted letters on  Form 8-K. Unless contrarily noted, Amgen is accouterment this advice as of the date of this account absolution and does not undertake any obligation to amend any advanced statements independent in this certificate as a aftereffect of new information, approaching contest or otherwise.

No advanced account can be affirmed and absolute after-effects may alter materially from those we project. Analysis or identification of new artefact candidates or development of new break for absolute articles cannot be affirmed and movement from abstraction to artefact is uncertain; consequently, there can be no acceding that any accurate artefact applicant or development of a new adumbration for an absolute artefact will be acknowledged and become a bartering product. Further, preclinical after-effects do not acceding safe and able achievement of artefact candidates in humans. The complication of the beastly anatomy cannot be perfectly, or sometimes, alike abundantly modeled by computer or corpuscle adeptness systems or beastly models. The breadth of time that it takes for us to complete analytic trials and admission authoritative approval for artefact business has in the accomplished assorted and we apprehend agnate airheadedness in the future. Alike back analytic trials are successful, authoritative authorities may catechism the capability for approval of the balloon endpoints we accept selected. We advance artefact candidates internally and through licensing collaborations, partnerships and collective ventures. Artefact candidates that are acquired from relationships may be accountable to disputes amid the parties or may prove to be not as able or as safe as we may accept believed at the time of entering into such relationship. Also, we or others could analyze safety, ancillary furnishings or accomplishment problems with our products, including our devices, afterwards they are on the market.

Our after-effects may be afflicted by our adeptness to auspiciously bazaar both new and absolute articles domestically and internationally, analytic and authoritative developments involving accepted and approaching products, sales advance of afresh launched products, antagonism from added articles including biosimilars, difficulties or delays in accomplishment our articles and all-around bread-and-butter conditions. In addition, sales of our articles are afflicted by appraisement pressure, political and accessible analysis and acceding behavior imposed by third-party payers, including governments, clandestine allowance affairs and managed affliction providers and may be afflicted by regulatory, analytic and guideline developments and calm and all-embracing trends against managed affliction and healthcare bulk containment. Furthermore, our research, testing, pricing, business and added operations are accountable to all-encompassing adjustment by calm and adopted government authoritative authorities. Our business may be impacted by government investigations, action and artefact accountability claims. In addition, our business may be impacted by the acceptance of new tax legislation or acknowledgment to added tax liabilities. If we abort to accommodated the acquiescence obligations in the accumulated candor acceding amid us and the U.S. government, we could become accountable to cogent sanctions. Further, while we commonly admission patents for our articles and technology, the aegis offered by our patents and apparent applications may be challenged, invalidated or baffled by our competitors, or we may abort to abound in present and approaching bookish acreage litigation. We accomplish a abundant bulk of our bartering accomplishment activities at a few key facilities, including in Puerto Rico, and additionally depend on third parties for a allocation of our accomplishment activities, and banned on accumulation may constrain sales of assertive of our accepted articles and artefact applicant development. We await on collaborations with third parties for the development of some of our artefact candidates and for the commercialization and sales of some of our bartering products. In addition, we attempt with added companies with account to abounding of our marketed articles as able-bodied as for the analysis and development of new products. Further, some raw materials, medical accessories and basic genitalia for our articles are supplied by sole third-party suppliers. Assertive of our distributors, barter and payers accept abundant purchasing advantage in their affairs with us. The analysis of cogent problems with a artefact agnate to one of our articles that accuse an absolute chic of articles could accept a actual adverse aftereffect on sales of the afflicted articles and on our business and after-effects of operations. Our efforts to coact with or admission added companies or products, and to accommodate the operations of companies or in abutment of articles we accept acquired, may not be successful. A breakdown, cyberattack or advice aegis aperture could accommodation the confidentiality, candor and availability of our systems and our data. Our banal amount is airy and may be afflicted by a cardinal of events. Our business achievement could affect or absolute the adeptness of our Board of Directors to acknowledge a allotment or our adeptness to pay a allotment or repurchase our accepted stock. We may not be able to admission the basic and acclaim markets on agreement that are favorable to us, or at all.

The accurate advice discussed in this account absolution apropos to any new break for our articles is basic and analytic and is not allotment of the labeling accustomed by the U.S. Food and Biologic Administration for the products. The articles are not accustomed for the investigational use(s) discussed in this account release, and no abstracts can or should be fatigued apropos the assurance or capability of the articles for these uses.

CONTACT: Amgen, Thousand Oaks
Trish Hawkins, 805-447-5631 (media)
Jessica Akopyan, 805-447-0974 (media)
Arvind Sood, 805-447-1060 (investors)

References         

 

 

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