THOUSAND OAKS, Calif.,
观看比赛直播 观看比赛直播 May 22, 2015 /PRNewswire/ --
世界杯直播频道 世界杯比赛时间 Amgen (NASDAQ: AMGN) today announced that the
观看比赛直播 观看比赛直播 世界杯直播频道 Committee for Medicinal Products for Human 世界杯直播频道 Use (CHMP) of the
世界杯比赛时间 European Medicines Agency 观看比赛直播 2026世界杯直播赛程 (EMA) has adopted a positive opinion for the marketing authorization of Repatha™ 2026世界杯直播赛程 (evolocumab) recommending approval for use in certain patients with high
世界杯直播频道 观看比赛直播 世界杯直播频道 cholesterol. Repatha is an investigational fully human monoclonal 世界杯直播频道 antibody that inhibits proprotein 世界杯直播频道 convertase subtilisin/kexin type 世界杯比赛时间 9 世界杯比赛时间 (PCSK9), a protein that reduces the liver's ability to remove low-density
世界杯直播频道 世界杯直播频道 lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.1
The CHMP recommended granting Repatha marketing authorization for:
-
世界杯直播频道 2026世界杯直播赛程 世界杯直播频道 The treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial [HeFH]) or mixed dyslipidemia, as an adjunct to diet:
2026世界杯直播赛程 世界杯直播频道 2026世界杯直播赛程
- in combination with a statin or statin with 世界杯直播频道 other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
- alone or in combination with other lipid-lowering therapies in patients who are 世界杯直播频道 statin-intolerant, or 世界杯直播频道 for whom a statin is contraindicated.
- The treatment of adults and adolescents aged 12 years and 世界杯比赛时间 over with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies.
The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.
"We are 世界杯直播频道 pleased to receive a positive opinion from the CHMP for Repatha as it is an important step in providing a new treatment 世界杯直播频道 option for patients with high cholesterol, who are unable to reach their LDL
世界杯比赛时间 观看比赛直播 世界杯直播频道 cholesterol goals with current 世界杯比赛时间 therapies in 观看比赛直播 the
观看比赛直播 世界杯直播频道 European Union," said
2026世界杯直播赛程 世界杯直播频道 世界杯比赛时间 世界杯直播频道 观看比赛直播 世界杯直播频道 观看比赛直播 世界杯直播频道 2026世界杯直播赛程 Sean E. Harper, M.D., executive vice 2026世界杯直播赛程 president of Research and Development at
世界杯直播频道 Amgen. "Uncontrolled high cholesterol is a burden on the health system and we look forward to continuing to work with 世界杯直播频道 regulatory authorities to bring Repatha 世界杯比赛时间 to patients across
世界杯比赛时间 世界杯直播频道 Europe."
The Icelandic and Norwegian CHMP members have also agreed with the above-mentioned recommendation on granting of the marketing authorization.
The CHMP positive opinion will now be reviewed by the European Commission (EC), which 世界杯直播频道 has the authority to approve medicines for the
世界杯比赛时间 世界杯直播频道 2026世界杯直播赛程 European Union (EU). If approved, a centralized marketing authorization with unified labeling will be granted in the 28 countries that are members of the EU.
世界杯比赛时间 世界杯直播频道 Norway,
2026世界杯直播赛程 观看比赛直播 2026世界杯直播赛程 Iceland and
世界杯比赛时间 世界杯直播频道 Liechtenstein, as members of the European Economic Area (EEA), 世界杯比赛时间 will take corresponding decisions on the basis of the decision of the EC.
The CHMP opinion is based on data from approximately 6,800 patients, including more 观看比赛直播 than 4,500 patients with high cholesterol in 10 Phase 3 trials. The Phase 3 studies evaluated the safety and efficacy of
观看比赛直播 Repatha in 世界杯直播频道 patients with elevated cholesterol, including patients on statins with or without 观看比赛直播 other lipid-lowering therapies; patients who cannot tolerate statins; patients with HeFH; and patients with
世界杯直播频道 世界杯比赛时间 HoFH, 世界杯直播频道 a rare and serious genetic disorder.2 世界杯直播频道
In
观看比赛直播 世界杯直播频道 2026世界杯直播赛程 2026世界杯直播赛程 Europe, up to 54 percent of the population aged 25 and older has a total cholesterol ≥5.0 mmol/L (≥190 mg/dL).3 High cholesterol, particularly elevated LDL-C, is the most common
世界杯比赛时间 2026世界杯直播赛程 form of dyslipidemia, which is an 世界杯比赛时间 abnormality of cholesterol and/or fats in the blood.4,5 Elevated LDL-C is recognized as a 世界杯比赛时间 major risk factor for cardiovascular disease.6,7
About Repatha™ (evolocumab)
Repatha™ (evolocumab) is a fully human monoclonal antibody 世界杯比赛时间 that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).1 世界杯比赛时间 世界杯直播频道 2026世界杯直播赛程 世界杯直播频道 世界杯直播频道 世界杯直播频道 PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.8 Repatha, being developed by
观看比赛直播 2026世界杯直播赛程 世界杯比赛时间 Amgen scientists, is designed to bind 观看比赛直播 to PCSK9 and inhibit PCSK9 from binding to LDL receptors 2026世界杯直播赛程 on the liver surface. In the absence of PCSK9, there are more 世界杯比赛时间 LDL receptors on the surface of the
世界杯直播频道 世界杯比赛时间 世界杯直播频道 liver to remove LDL-C from the 世界杯比赛时间 blood.1
The U.S. Food and Drug Administration (
世界杯比赛时间 世界杯比赛时间 2026世界杯直播赛程 世界杯比赛时间 2026世界杯直播赛程 FDA) and EMA have provisionally approved the use of the trade name Repatha.
About PROFICIO: Repatha™ (evolocumab) Clinical Trial Program
PROFICIO, which stands for the Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of 世界杯比赛时间 PCSK9 In Different POpulations,
世界杯比赛时间 世界杯直播频道 世界杯直播频道 is a large 世界杯比赛时间 and comprehensive clinical trial program evaluating Repatha™ (evolocumab) in 22 clinical trials, 世界杯直播频道 with 世界杯直播频道 a combined planned enrollment of approximately 35,000 patients. 世界杯比赛时间
The Phase 3 program includes 16 trials to evaluate Repatha administered every two weeks and monthly in multiple patient populations, including in combination with statins in patients with hyperlipidemia
世界杯比赛时间 (LAPLACE-2 and YUKAWA-2); in 观看比赛直播 patients with hyperlipidemia who cannot tolerate statins (GAUSS-2 世界杯直播频道 and GAUSS-3); as a stand-alone treatment in patients 世界杯比赛时间 with hyperlipidemia (MENDEL-2); in patients whose elevated
世界杯比赛时间 世界杯直播频道 cholesterol is caused by genetic disorders called heterozygous 观看比赛直播 (RUTHERFORD-2 and TAUSSIG) and homozygous (TESLA and TAUSSIG) familial hypercholesterolemia; the effects 世界杯比赛时间 of Repatha on lipoprotein metabolism
(FLOREY); and the administration of Repatha in statin-treated hyperlipidemic patients (THOMAS-1 and THOMAS-2).
Five ongoing studies in the Repatha Phase 3 program will provide long-term safety and efficacy data. 世界杯比赛时间 世界杯直播频道 These include FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition
世界杯比赛时间 in Subjects with Elevated Risk), which 观看比赛直播 will assess whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces recurrent
cardiovascular events in approximately 27,500 patients with cardiovascular disease; EBBINGHAUS (Evaluating PCSK9 Binding AntiBody Influence oN CoGnitive HeAlth
世界杯直播频道 in High CardiovascUlar Risk Subjects), 世界杯直播频道 which will evaluate the effect of Repatha on cognitive function in a subset of 2026世界杯直播赛程 patients enrolled in FOURIER; OSLER-2 (Open Label Study
世界杯比赛时间 世界杯直播频道 of Long TERm Evaluation Against LDL-C Trial-2) in 世界杯直播频道 patients with high cholesterol who completed any of the Phase 3 studies; GLAGOV (GLobal Assessment of Plaque ReGression
世界杯比赛时间 2026世界杯直播赛程 with a PCSK9 AntibOdy as Measured by 世界杯比赛时间 IntraVascular Ultrasound), which will determine 世界杯比赛时间 the effect of Repatha on 世界杯直播频道 coronary atherosclerosis in 世界杯比赛时间 approximately 950 patients undergoing cardiac catheterization;
观看比赛直播 观看比赛直播 世界杯比赛时间 世界杯直播频道 and TAUSSIG (Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects with Genetic 世界杯比赛时间 LDL Disorders), which will assess the long-term safety and efficacy of
世界杯直播频道 Repatha on LDL-C in patients with severe familial hypercholesterolemia including patients with homozygous familial hypercholesterolemia. The DESCARTES 世界杯直播频道 世界杯比赛时间 世界杯直播频道 (Durable Effect of 观看比赛直播 PCSK9
2026世界杯直播赛程 Antibody
世界杯比赛时间 2026世界杯直播赛程 世界杯比赛时间 CompARed wiTh PlacEbo Study) study, a long-term safety and efficacy trial in patients with hyperlipidemia at risk for cardiovascular disease, has completed.
About Amgen Cardiovascular
Building on 2026世界杯直播赛程 more than three decades of experience in developing biotechnology medicines for patients with serious illnesses,
世界杯比赛时间 世界杯直播频道 世界杯直播频道 世界杯比赛时间 观看比赛直播 Amgen 世界杯直播频道 世界杯比赛时间 is dedicated to addressing important scientific questions to advance care and improve the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide.9
Amgen's research into cardiovascular disease, and potential treatment options, is 世界杯直播频道 part of a growing competency at
世界杯直播频道 观看比赛直播 世界杯直播频道 世界杯比赛时间 Amgen that utilizes 世界杯直播频道 human genetics to identify and validate certain drug targets. Through 世界杯比赛时间 its own research and development efforts, as well as partnerships,
Amgen is building 世界杯直播频道 a robust cardiovascular pipeline consisting of several investigational molecules in an effort to address a number of today's important unmet patient needs, such as high cholesterol
世界杯比赛时间 世界杯直播频道 and heart failure.
About Amgen
Amgen is committed 世界杯直播频道 to unlocking the potential of biology for patients suffering from serious illnesses 世界杯直播频道 by 世界杯比赛时间 discovering, developing, manufacturing and delivering innovative
观看比赛直播 观看比赛直播 世界杯直播频道 世界杯直播频道 观看比赛直播 human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of 2026世界杯直播赛程 high unmet medical 世界杯直播频道 need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and 世界杯比赛时间 dramatically improve people's lives. A
世界杯直播频道 世界杯直播频道 观看比赛直播 2026世界杯直播赛程 观看比赛直播 biotechnology pioneer 世界杯比赛时间 since 1980, Amgen has grown to be one of the world's leading independent biotechnology 世界杯直播频道 companies, has reached millions of patients around the world and 观看比赛直播 is developing a
世界杯直播频道 观看比赛直播 世界杯直播频道 世界杯直播频道 世界杯直播频道 pipeline of medicines with breakaway potential.
For more information, visit http://www.amgen.com/ and follow us on www.twitter.com/amgen.
世界杯比赛时间 世界杯直播频道
Forward-Looking 世界杯直播频道 Statements
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties
世界杯比赛时间 世界杯比赛时间 世界杯比赛时间 世界杯比赛时间 and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking
世界杯直播频道 世界杯直播频道 世界杯直播频道 2026世界杯直播赛程 2026世界杯直播赛程 statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices,
观看比赛直播 世界杯比赛时间 customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. 世界杯比赛时间 Forward-looking statements involve significant risks and uncertainties, including
世界杯比赛时间 2026世界杯直播赛程 those discussed below and more fully 世界杯直播频道 described in the
世界杯比赛时间 世界杯比赛时间 Securities and Exchange Commission (
世界杯比赛时间 世界杯比赛时间 SEC) reports filed by
世界杯比赛时间 观看比赛直播 世界杯比赛时间 2026世界杯直播赛程 世界杯直播频道 Amgen, including
世界杯比赛时间 世界杯直播频道 观看比赛直播 Amgen's most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to
2026世界杯直播赛程 世界杯直播频道 Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our 世界杯直播频道 business. Unless otherwise noted,
世界杯比赛时间 Amgen is providing this information as of
世界杯直播频道 世界杯比赛时间 May 22, 观看比赛直播 世界杯直播频道 2015, and expressly disclaims any duty to update information 世界杯比赛时间 contained in this news release.
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
世界杯直播频道 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
世界杯直播频道 观看比赛直播 世界杯比赛时间 世界杯比赛时间 for an existing product will 观看比赛直播 be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in 世界杯直播频道 humans. The 2026世界杯直播赛程 complexity
观看比赛直播 of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or 世界杯直播频道 cell culture systems or animal models. The length of time that it takes for us to complete clinical trials
世界杯直播频道 and obtain regulatory 世界杯比赛时间 approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations,
观看比赛直播 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
2026世界杯直播赛程 世界杯直播频道 世界杯比赛时间 at the 世界杯比赛时间 time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. 世界杯比赛时间 Our business may be impacted
2026世界杯直播赛程 世界杯直播频道 世界杯比赛时间 by government investigations, litigation and products liability claims. We depend on third parties 世界杯直播频道 for a significant 观看比赛直播 portion of our manufacturing capacity for the supply of certain of our current and
世界杯比赛时间 2026世界杯直播赛程 2026世界杯直播赛程 观看比赛直播 future products and limits 2026世界杯直播赛程 on supply may constrain sales of certain of our 世界杯直播频道 current products and product 2026世界杯直播赛程 candidate development.
In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected
世界杯直播频道 by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare 观看比赛直播 cost 世界杯直播频道 containment as well as U.S. legislation affecting pharmaceutical pricing
世界杯直播频道 2026世界杯直播赛程 世界杯比赛时间 观看比赛直播 2026世界杯直播赛程 世界杯比赛时间 and reimbursement. Government and others' regulations and reimbursement policies may affect the development, 2026世界杯直播赛程 usage 观看比赛直播 and pricing of our products. In addition, we compete with other companies with respect
世界杯直播频道 世界杯比赛时间 世界杯直播频道 to some of our marketed products as well as for the discovery and development of new products. We believe 世界杯直播频道 that some of our newer products, product candidates or new indications for existing products,
世界杯直播频道 世界杯直播频道 may face competition when and as they are approved and marketed. Our products may compete against 世界杯比赛时间 products that have lower prices, established reimbursement, superior performance, are easier to administer,
世界杯比赛时间 or that are 2026世界杯直播赛程 otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may
世界杯直播频道 世界杯直播频道 be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. 世界杯直播频道 We cannot guarantee
世界杯直播频道 观看比赛直播 世界杯比赛时间 2026世界杯直播赛程 that we will be able to produce commercially successful products 世界杯比赛时间 观看比赛直播 or maintain the commercial success of our existing products. 世界杯比赛时间 Our stock price may 世界杯比赛时间 be affected by actual or perceived market 世界杯比赛时间 opportunity,
世界杯直播频道 世界杯比赛时间 观看比赛直播 competitive position, and success or failure of our products or product candidates. Further, the discovery 世界杯比赛时间 of 2026世界杯直播赛程 significant 观看比赛直播 problems with a 世界杯直播频道 product similar to one of our products that implicate an entire
世界杯比赛时间 class of products 世界杯比赛时间 could have a material adverse effect on sales of 世界杯比赛时间 the affected products and on our business and results of operations. Our efforts to integrate the operations of companies we have acquired
世界杯直播频道 世界杯直播频道 观看比赛直播 世界杯直播频道 may not be successful. We may experience difficulties, delays or unexpected costs and not 世界杯比赛时间 achieve anticipated benefits and savings from our 世界杯直播频道 recently 世界杯比赛时间 announced restructuring plan. Our business performance
观看比赛直播 观看比赛直播 could affect or limit the ability of our Board of Directors to declare a dividend or 世界杯比赛时间 their ability to pay a dividend or repurchase our common stock.
The scientific information discussed 世界杯比赛时间 in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
世界杯比赛时间 世界杯直播频道 世界杯直播频道 U.S. Food and Drug Administration (
世界杯比赛时间 世界杯比赛时间 FDA), the
世界杯比赛时间 世界杯直播频道 世界杯直播频道 European Medicines Agency (EMA) or other 世界杯直播频道 similar regulatory bodies, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.
CONTACT:
世界杯比赛时间 Amgen,
世界杯直播频道 观看比赛直播 Thousand Oaks
Trish Hawkins, 805-447-5631 (media)
Kristen Davis, 805-447-3008 (media)
Arvind Sood, 805-447-1060 (investors)
Amgen, European Union
Emma Gilbert, +41 41 369 2542
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- Amgen Data on File, Investigator Brochure.
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National Human Genome Research 世界杯比赛时间 Institute. Learning About Familial Hypercholesterolemia. http://www.genome.gov/25520184.
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世界杯比赛时间 2026世界杯直播赛程 May 2015.
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World Health Organization:
世界杯比赛时间 观看比赛直播 2026世界杯直播赛程 2026世界杯直播赛程 世界杯直播频道 Global Health Observatory (GHO) data; Raised Cholesterol situations and trends; WHO 2015. http://www.who.int/gho/ncd/risk_factors/cholesterol_text/en/
观看比赛直播 世界杯比赛时间
-
World Health Organization. 世界杯直播频道 Quantifying Selected Major Risks to Health. In: The World Health Report 2002 - 世界杯比赛时间 Reducing Risks, Promoting Healthy 2026世界杯直播赛程 Life. Chapter 4:
Geneva: World.
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2026世界杯直播赛程 2026世界杯直播赛程 Merck Manuals. website. http://www.merckmanuals.com/professional/endocrine_and_metabolic_disorders/lipid_disorders/dyslipidemia.html.
世界杯直播频道 世界杯直播频道 世界杯比赛时间 Accessed
观看比赛直播 May 2015.
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American Heart Association (2012). Why Cholesterol Matters. 世界杯比赛时间 http://www.heart.org/HEARTORG/Conditions/Cholesterol/WhyCholesterolMatters/Why-Cholesterol-Matters_UCM_001212_Article.jsp. Accessed
2026世界杯直播赛程 2026世界杯直播赛程 世界杯比赛时间 世界杯比赛时间 观看比赛直播 May 2015.
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World Health Organization. Global Status Report on Noncommunicable Diseases 世界杯比赛时间 2010.
2026世界杯直播赛程 世界杯比赛时间 2026世界杯直播赛程 Geneva, 2011.
- Qian Y-W, Schmidt RJ, Zhang Y et al. Secreted PCSK9 downregulates low density lipoprotein receptor through receptor-mediated endocytosis. J. Lipid Res. 2007. 48: 1488–1498.
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World Health Organization. Cardiovascular diseases (CVDs) fact sheet. http://www.who.int/mediacentre/factsheets/fs317/en/.
世界杯比赛时间 世界杯比赛时间 2026世界杯直播赛程 Accessed
2026世界杯直播赛程 2026世界杯直播赛程 世界杯直播频道 May 2015.
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