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NEW AMGEN DATA TO BE PRESENTED AT ESC CONGRESS 2019 HIGHLIGHT ADDITIONAL EVIDENCE FOR REPATHA (EVOLOCUMAB) EFFECTIVENESS IN CARDIOVASCULAR DISEASE ACROSS MULTIPLE PATIENT GROUPS

Pressmeddelande   •   Aug 29, 2019 13:21 CEST

Amgen (NASDAQ:AMGN) today announced the presentation of 14 cardiovascular scientific research abstracts, including studies evaluating the safety and efficacy of Repatha (evolocumab) by race and ethnicity and further examining its clinical benefit in patients with familial hypercholesterolemia (FH).1,2The data will be presented at ESC Congress 2019, organized by the European Society of Cardiology, in Paris, Aug. 31–Sept. 4.

Further independent data, generated in Europe, will be presented for Repatha from the EVOlocumab for early reduction of LDL-cholesterol levels in Patients with AcuteCoronary Syndromes (EVOPACS) study.3

“Cardiovascular disease is one of the greatest health challenges we face today, impacting more than 49 million people in the EU alone.4While it is critical to reduce low-density lipoprotein cholesterol (LDL-C) levels in patients who have had multiple cardiovascular events or a recent heart attack, we continue to see elevated LDL-C in high-risk patients, despite treatment with statins and other traditional lipid-lowering therapies,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Amgen is committed to building a body of evidence to support the clinical profile of Repatha and demonstrate its high value in patients at elevated risk of suffering another event.”

Lowering LDL-C, or “bad” cholesterol, is a key modifiable risk factor in reducing the risk of cardiovascular events such as heart attack and stroke.5Alongside ESC Congress 2019, Amgen is hosting #ProtectUrLife, an innovative, European-city-based heart screening and education program at the ESC Congress public event in Paris. Members of the public will be offered a free non-invasive screening that measures cholesterol levels, one of the most important risk factors associated with an increased risk of heart attack.

“Our #ProtectUrLife screening and education program aims to improve the prevention, evaluation and care of serious medical conditions, including cardiovascular disease, that continue to be underdiagnosed and undermanaged. Moving on from the traditional ‘break and fix’ approach, the program uses a ‘predict and prevent’ model, providing education on risk reduction and empowering the public to act on knowledge to help prevent life-altering events such as heart attacks and stroke,” said Isma Benattia, M.D., vice president of Medical for the European Region at Amgen.

The two-day #ProtectUrLife event will be held at the Public Event Village in front of the Hôtel de Ville in Paris from 11 a.m. to 7 p.m. CEST during the weekend of Aug. 31–Sept. 1, 2019. The Public Event Village is organized by the ESC, the City of Paris and the French Society of Cardiology, and around 10,000 visitors are expected to attend each day.

A list of Amgen-sponsored abstracts at ESC Congress 2019 can be found online and below:

  • Effectiveness of evolocumab for patients with familial hypercholesterolemia (FH) in European clinical practice
    • Clinical profile of patients initiating evolocumab in Spanish Cardiology Units: A RETrospective, ObservationalStudy of Real-World Clinical Practice (RETOSS-Cardio)
    • Hypertension risk factors and lifestyle, Sunday, Sept. 1, 10:05-10:55 a.m. CET
    • Cost-effectiveness of evolocumab in patients with high atherosclerotic cardiovascular risk in Sweden
      • Effect of evolocumab on lipoprotein(a) levels: results across 15 studies
      • Lipids, Tuesday, Sept. 3, 10:05-10:55 a.m. CET
      • Effects of evolocumab on LDL-C by race and ethnicity: an analysis of double-blind and open-label extension studies
        • Lower use of statins among patients with peripheral artery disease compared with those with coronary heart disease
        • Lipids, Saturday, Aug. 31, 12:35-1:25 p.m. CET
        • Association of adherence and treatment intensity of lipid-lowering therapy with cardiovascular outcomes and all-cause mortality in very high-risk patients in Germany
        • Lipids, Saturday, Aug. 31, 12:35-1:25 p.m. CET
        • Screening and treatment of familial hypercholesterolemia (FH) in a French sample of ambulatory care: a retrospective longitudinal study
          • Patient characteristics and treatment patterns in patients on lipid-lowering therapies following an acute coronary syndrome in France
          • Lipids, Saturday, Aug. 31, 12:35-1:25 p.m. CET
          • Oxidized phospholipids on apolipoprotein B-100 among black U.S. adults with and without PCSK9 loss-of-function variants
            • Electronic health records (EHRs) data validation in atherosclerotic/cardiovascular clinical phenotypes
            • Digital health, Saturday, Aug. 31, 12:35-1:25 p.m. CET
            • Contrasting the risk for atherosclerotic cardiovascular disease events among individuals with lower extremity peripheral artery disease, coronary heart disease and cerebrovascular disease
              • Recurrent coronary heart disease in the year following myocardial infarction among U.S. men and women between 2008 and 2015
                • Death, debility, and destitution following recurrent myocardial infarction in older adults
                  • EVOlocumab for early reduction of LDL-cholesterol levels in Patients with Acute Coronary Syndromes (EVOPACS) – A randomized, double-blind, placebo-controlled multicenter study (ISS)
                  • Acute Coronary Syndromes, Late-Breaking Science, Saturday, Aug. 31, 09:17 a.m. CET

About Repatha (evolocumab)6

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 approved in more than 60 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union. Applications in other countries are pending.

Hypercholesterolaemia and mixed dyslipidaemia

Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia, as an adjunct to diet:

  • in combination with a statin or statin with 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 statin-intolerant, or for whom a statin is contraindicated.

Homozygous familial hypercholesterolaemiaRepatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.

Established atherosclerotic cardiovascular diseaseRepatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:

  • in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
  • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

References

1Effects of evolocumab on LDL-C by race and ethnicity: an analysis of double-blind and open-label extension studies. Presented at ESC 2019, Lipids, Tuesday 3 September, 15:50-16:40 CET.

2Effectiveness of evolocumab for patients with familial hypercholesterolaemia (FH) in European clinical practice. Presented at ESC 2019, Lipids, Saturday 31 August, 12:35-13:25 CET.

3EVOlocumab for early reduction of LDL-cholesterol levels in Patients with Acute Coronary Syndromes (EVOPACS) – A randomized, double-blind, placebo-controlled multicenter study (ISS) Acute Coronary Syndromes, Late-Breaking Science, Saturday, Aug. 31, 09:17 CET.

4Wilkins E, Wilson L, Wickramasinghe K, Bhatnagar P, Leal J, Luengo-Fernandez R, Burns R, Rayner M, Townsend N (2017). European Cardiovascular Disease Statistics 2017. European Heart Network, Brussels.

5 American Heart Association (2017): What your cholesterol levels mean

https://www.heart.org/en/health-topics/cholesterol/about-cholesterol/what-your-cholesterol-levels-meanAccessed July 2019

6Repatha Prescribing Information; Amgen, Thousand Oaks, CA, 2018.

7 World Health Organization. Cardiovascular diseases (CVDs) fact sheet. http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed July 2019

About Amgen in the Cardiovascular Therapeutic Area

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.7Amgen's 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 today's important unmet patient needs, such as high cholesterol and heart failure.