Amgen (AMGN) To Present Robust Data Exploring The Impact Of Treatment With Repatha®

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Amgen To Present Robust Data Exploring The Impact Of Treatment With Repatha® (evolocumab) Across Patient Subgroups And High-Risk Populations At ESC Congress 2018

New Research Evaluates the Benefit of LDL-C Lowering With Repatha Across Gender and Age

Data Assesses the Financial Burden for Patients in Europe With Atherosclerotic Cardiovascular Disease

Amgen (AMGN) today announced the upcoming presentation of new Repatha® (evolocumab) analyses, including a late-breaking study evaluating the efficacy of Repatha in patients with metabolic syndrome and established cardiovascular disease at the ESC Congress 2018, organized by the European Society of Cardiology, in MunichAug. 25-29.

Six abstracts, including two analyses from the Repatha cardiovascular outcomes study (FOURIER), will be presented, providing further insight into the efficacy and safety of Repatha among a variety of patient groups. Data on the residual risk and financial burden for patients with atherosclerotic cardiovascular disease (ASCVD) across Europe will also be presented.

“For some high-risk patients, statins and other traditional lipid-lowering therapies are not enough to reduce elevated low-density lipoprotein cholesterol (LDL-C). This is particularly critical in patients who have had multiple events or a recent cardiovascular event. Data to be presented at ESC Congress 2018 reinforces the role of Repatha as a proven, effective and safe treatment option for these patients,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Amgen continues to build a robust body of clinical evidence that demonstrates Repatha provides extremely potent LDL lowering efficacy and is, therefore, of high clinical and economic value.”

A full list of Amgen-sponsored abstracts at ESC Congress 2018 can be found online and below:

Evolocumab Research
Late-Breaking Science Session

  • FOURIER – Efficacy of PCSK9 inhibition with evolocumab in patients with Metabolic Syndrome
    Late Breaking Pharmacological Science, Saturday, Aug. 2511 a.m. – 12:30 p.m. CEST

Oral Presentation

  • Benefit of LDL-C lowering with evolocumab on cardiovascular outcomes by age & sex: an analysis of the FOURIER trial
    PCSK9 inhibitors – for the many or the few? Tuesday, Aug. 288:30 a.m. – 10 a.m. CEST

Poster Sessions

  • Residual risk following myocardial infarction despite intensive medical management
    Poster Session 1: Antiplatelet and anticoagulant drugs, Saturday, Aug. 2511 a.m. – 4 p.m. CEST
  • Assessment of cardiovascular disease risk using different thresholds to define high risk on the pooled cohort equations
    Atrial fibrillation, stroke and cardiovascular risk, Saturday, Aug. 2512:35 p.m. – 1:25 p.m. CEST
  • Characteristics of patients prescribed evolocumab in Europe, Does clinical use match clinical guidelines?
    Poster Session 2: Coronary artery disease epidemiology and outcomes, Sunday, Aug. 26, 8:30 a.m. – 12:30 p.m. CEST
  • Patient and caregiver productivity loss and indirect costs associated with cardiovascular events in Europe
    Poster Session 3: Health economics, Sunday, Aug. 262 p.m. – 6 p.m. CEST

Repatha Cardiovascular Outcomes (FOURIER) Study Design
FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a multinational Phase 3 randomized, double-blind, placebo-controlled 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 (LDL-C ≥70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL) and clinically evident atherosclerotic cardiovascular disease at more than 1,300 study locations around the world were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 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 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. The study was event driven and continued until at least 1,630 patients experienced a key secondary endpoint.

About Repatha® (evolocumab)
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.1

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.

Important EU Product Information

In Europe Repatha is approved for use in:

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

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