"Amgen NASDAQ AMGN httpstudio.financialcontent.comprnewsPageQuoteTickerAMGN today announced that the FOURIER trial evaluating whether Repatha evolocumab reduces the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease ASCVD met its primary composite endpoint cardiovascular death nonfatal myocardial infarction MI nonfatal stroke hospitalization for unstable angina or coronary revascularization and the key secondary composite endpoint cardiovascular death nonfatal MI or nonfatal stroke. No new safety issues were observed. The EBBINGHAUS cognitive function trial conducted in FOURIER patients also achieved its primary endpoint demonstrating that Repatha was noninferior to placebo for the effect on cognitive function.   Detailed results from the Repatha FOURIER outcomes trial will be presented at the American College of Cardiology ACC th Annual Scientific Session LateBreaking Clinical Trials session in Washington D.C. on Friday March  at  a.m. ET. Detailed results from the Repatha EBBINGHAUS cognitive function trial will be presented at the LateBreaking Clinical Trials session on Saturday March  at  a.m. ET. In the GLAGOV study we demonstrated that Repatha has an effect on atherosclerosis the underlying cause of cardiovascular disease. These FOURIER results show unequivocally the connection between lowering LDL cholesterol with Repatha and cardiovascular risk reduction even in a population already treated with optimized statin therapy said Sean E. Harper M.D. executive vice president of Research and Development at Amgen. Cardiovascular disease remains the number one health burden in the world and we look forward to sharing these outcomes data with the scientific community at the  ACC th Annual Scientific Session. FOURIER Further Cardiovascular OUtcomes Research with PCSK Inhibition in Subjects with Elevated Risk is a multinational Phase  doubleblind randomized placebocontrolled trial in approximately  patients who had either an MI an ischemic stroke or symptomatic peripheral artery disease and an LDL  mgdL or a nonHDLC  mgdL on optimized statin therapy. Optimized statin therapy was defined as at least atorvastatin  mg or equivalent daily with a recommendation for at least atorvastatin  mg or equivalent daily where approved. Patients were randomized to receive Repatha subcutaneous  mg every two weeks or  mg monthly or placebo subcutaneous every two weeks or monthly. The study continued until at least  patients experienced a key secondary MACE major adverse cardiac event endpoint of cardiovascular death MI or stroke whichever occured first. EBBINGHAUS Evaluating PCSK Binding antiBody Influence oN coGnitive HeAlth in high cardiovascUlar risk Subjects is a doubleblind placebocontrolled randomized noninferiority trial involving approximately  patients enrolled in the FOURIER outcomes study. Executive function Spatial Working Memory strategy index  primary endpoint and secondary endpoints of working memory memory function and psychomotor speed were assessed using a tabletbased tool CANTAB at baseline and select time points.   Cardiovascular disease is the leading cause of death worldwide. In the U.S. there are approximately  million people with ASCVD andor familial hypercholesterolemia FH who have uncontrolled levels of lowdensity lipoprotein LDLC over  mgdL despite treatment with statins or other cholesterollowering therapies. More than  percent of highrisk patients in Europe are still unable to adequately lower their LDLC levels with statins or other currently approved lipidlowering agents. Among very highrisk patients the percentage is increased to more than  percent. It is estimated that less than one percent of people with FH heterozygous and homozygous forms in most countries are diagnosed.   FOURIER Study Design  FOURIER a multinational Phase  randomized doubleblind placebocontrolled trial is designed to evaluate whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The primary endpoint is the time to cardiovascular death myocardial infarction stroke hospitalization for unstable angina or coronary revascularization. The key secondary endpoint is the time to cardiovascular death myocardial infarction or stroke.    Eligible patients with high cholesterol LDLC  mgdL or nonhighdensity lipoprotein cholesterol nonHDLC  mgdL and clinically evident ASCVD at more than  study locations around the world were randomized to receive Repatha subcutaneous  mg every two weeks or  mg monthly plus effective statin dose or placebo subcutaneous every two weeks or monthly plus effective statin dose. Optimized statin therapy was defined as at least atorvastatin  mg or equivalent daily with a recommendation for at least atorvastatin  mg or equivalent daily where approved. The study was event driven and continued until at least  patients experienced a key secondary endpoint. EBBINGHAUS Study Design  EBBINGHAUS Evaluating PCSK Binding antiBody Influence oN coGnitive HeAlth in high cardiovascUlar risk Subjects is a doubleblind placebocontrolled randomized noninferiority trial involving approximately  patients enrolled in the FOURIER outcomes study.  The primary endpoint in the study is the Spatial Working Memory strategy index of executive function. Secondary endpoints are working memory as assessed by the CANTAB Spatial Working Memory SWM test betweenerrors score memory function as assessed by the CANTAB Paired Associates Learning PAL test and psychomotor speed as assessed by the CANTAB Reaction Time RTI test. About Repatha evolocumab Repatha evolocumab is a human monoclonal antibody that inhibits proprotein convertase subtilisinkexin type  PCSK. Repatha binds to PCSK and inhibits circulating PCSK from binding to the lowdensity lipoprotein LDL receptor LDLR preventing PCSKmediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK to LDLR Repatha increases the number of LDLRs available to clear LDL from the blood thereby lowering LDLC levels. Repatha is approved in more than  countries including the U.S. Japan Canada and in all  countries that are members of the European Union. Applications in other countries are pending. Important U.S. Product Information Repatha is indicated as an adjunct to diet and  Maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia HeFH or clinical atherosclerotic cardiovascular disease ASCVD who require additional lowering of lowdensity lipoprotein cholesterol LDLC   Other LDLlowering therapies e.g. statins ezetimibe LDL apheresis in patients with homozygous familial hypercholesterolemia HoFH who require additional lowering of LDLC The effect of Repatha on cardiovascular morbidity and mortality has not been determined. The safety and effectiveness of Repatha have not been established in pediatric patients with HoFH who are younger than  years old. The safety and effectiveness of Repatha have not been established in pediatric patients with primary hyperlipidemia or HeFH. Important U.S. Safety Information Contraindication Repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha. Allergic reactions Hypersensitivity reactions e.g. rash urticaria have been reported in patients treated with Repatha including some that led to discontinuation of therapy. If signs or symptoms of serious allergic reactions occur discontinue treatment with Repatha treat according to the standard of care and monitor until signs and symptoms resolve. Adverse reactions The most common adverse reactions  of Repathatreated patients and more common than placebo were nasopharyngitis upper respiratory tract infection influenza back pain and injection site reactions. In a week trial adverse reactions led to discontinuation of treatment in . of Repathatreated patients and  of placebotreated patients. The most common adverse reaction that led to Repatha treatment discontinuation and occurred at a rate greater than placebo was myalgia . versus  for Repatha and placebo respectively. Adverse reactions from a pool of the week trial and seven week trials Local injection site reactions occurred in . and . of Repatha treated and placebotreated patients respectively. The most common injection site reactions were erythema pain and bruising. The proportions of patients who discontinued treatment due to local injection site reactions in Repatha treated patients and placebotreated patients were . and  respectively. Allergic reactions occurred in . and . of Repatha treated and placebotreated patients respectively. The most common allergic reactions were rash . versus . for Repatha and placebo respectively eczema . versus . erythema . versus . and urticaria . versus .. Neurocognitive events were reported in less than or equal to . in Repathatreated and placebotreated patients. In a pool of placebo and activecontrolled trials as well as openlabel extension studies that followed them a total of  patients treated with Repatha had at least one LDLC value  mgdL. Changes to background lipidaltering therapy were not made in response to low LDLC values and Repatha dosing was not modified or interrupted on this basis. Although adverse consequences of very low LDLC were not identified in these trials the longterm effects of very low levels of LDLC induced by Repatha are unknown. Musculoskeletal adverse reactions were reported in . of Repatha treated patients and . of placebotreated patients. The most common adverse reactions that occurred at a rate greater than placebo were back pain . versus . for Repatha and placebo respectively arthralgia . versus . and myalgia . versus .. Homozygous Familial Hypercholesterolemia HoFH In  patients with homozygous familial hypercholesterolemia studied in a week doubleblind randomized placebocontrolled trial  patients received  mg of  Repatha subcutaneously once monthly. The adverse reactions that occurred in at least  . Repathatreated patients and more frequently than in placebotreated patients included upper respiratory tract infection . versus . influenza . versus  gastroenteritis . versus  and nasopharyngitis . versus . Immunogenicity Repatha is a human monoclonal antibody. As with all therapeutic proteins there is a potential for immunogenicity with Repatha.  Please contact Amgen Medinfo at AMGEN  or REPATHA  regarding Repatha availability or find more information including full Prescribing Information at  http and  http About Amgen Cardiovascular Building on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses Amgen 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. Amgens research into cardiovascular disease and potential treatment options is part of a growing competency at Amgen that utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts as well as partnerships Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules in an effort to address a number of todays important unmet patient needs such as high cholesterol and heart failure. About Amgen  Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering developing manufacturing and delivering innovative 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 high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since  Amgen has grown to be one of the worlds leading independent biotechnology companies has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information visit  http and follow us on  http ForwardLooking Statements This news release contains forwardlooking 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 forwardlooking statements including 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 and other such estimates and results. 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The scientific information discussed in this news release relating to new indications is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration or European Commission for the products. The products are not approved for the investigational uses discussed in this news release and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. CONTACT Amgen Thousand Oaks Kristen Davis  media Kristen Neese  media Arvind Sood  investors REFERENCES . World Health Organization. Cardiovascular diseases CVDs fact sheet. http  Accessed August .  . Amgen Data on File.  . Centers for Disease Control and Prevention. Vital signs prevalence treatment and control of high levels of lowdensity lipoprotein cholesterol. United States  and . MMWR. .  . Halcox JP et al. Low Rates of Both LipidLowering Therapy Use and Achievement of LowDensity Lipoprotein Cholesterol Targets in Individuals at HighRisk for Cardiovascular Disease across Europe. PLoS One. .  . Nordestgaard BG Chapman MJ Humphries SE et al. Familial Hypercholesterolaemia is Underdiagnosed and Undertreated in the General Population Guidance for Clinicians to Prevent Coronary Heart Disease. Eur Heart J. .  . Repatha U.S. Prescribing Information. Amgen. SOURCE Amgen Related Links http"