AMGEN PRESENTS NEW CARDIOVASCULAR RESEARCH AT AHA 2023
New Repatha® (evolocumab) Data Show No Decline in Cognitive Function Associated With Very Low Levels of LDL-C
Repatha Data Reinforces Benefits of Low LDL-C
Data from the EBBINGHAUS sub-study of the FOURIER-OLE is the first to evaluate the impact of long-term lowering of LDL-C on cognitive function following administration of Repatha in adult patients with atherosclerotic cardiovascular disease (ASCVD). The data showed patients treated with Repatha did not experience any apparent cognitive decline following a median achieved LDL-C of 34 mg/dL through a median follow-up period of 5.1 years.
"Cardiovascular disease is a leading public health crisis in
An additional analysis combining FOURIER and FOURIER-OLE data for 152 OLE participants originally randomized to receive Repatha showed that long-term treatment with this medication had no significant impact on measures of executive function, working and episodic memory, and psychomotor speed over time as compared to baseline. No new safety signals were identified in the analyses.
"The neurocognitive data highlighting long-term use of evolocumab is highly encouraging for the cardiovascular community," said
LDL-C Action Summit & LDL Awareness to Action Implementation Consortium
For more information on the
Abstracts and Presentation Times:
- Long-Term Efficacy of Evolocumab in Patients With and Without Multivessel Coronary Artery Disease (FOURIER OLE)
Abstract #Sa3071, Poster Session, Zone 3, Science and Technology Hall, Level 2,
Saturday, Nov. 11from 3-4:15 p.m. EST
- Association Between Achieved LDL-C Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE
Invited Encore Oral Presentation, Room 121B,
Sunday, Nov. 12from 3:30-3:35 p.m. EST (previously published in Circulation, Feb. 2023)
- Low Rates of Achievement of LDL-C<55dL Among Patients with ASCVD in
the United States: Findings from the cvMOBIUS Registry
Abstract #Su3278, Poster Session, Zone 3, Science and Technology Hall, Level 2, Hall A-D,
Sunday, Nov. 12from 3-4:15 p.m. EST
- Racial/Ethnic Disparities in Low-Density Lipoprotein Cholesterol Testing Following Myocardial Infarction Hospitalization Among Medicare Beneficiaries in
the United States, by State
Abstract #Su3242, Poster Session, Zone 3, Science and Technology Hall, Level 2, Sunday, Nov. 12 from 11:30 a.m.-
12:45 p.m. EST
- Long-Term Neurocognitive Safety of LDL-C Lowering With Evolocumab: Open-Label Extension Data From FOURIER
Abstract #304, Oral Presentation, Room 204C,
Monday, Nov. 13from 10:30-10:40 a.m. EST
- Persistence and Adherence to Proprotein Convertase Subtilisin/kexin type 9 Monoclonal Antibodies and Ezetimibe in Real-World Settings
Abstract #Mo3065, Poster Session, Zone 3, Science and Technology Hall, Level 2,
Monday, Nov. 13from 10:30-11:45 a.m. EST
- 104-Week Safety and Effectiveness of Low-Density Lipoprotein Cholesterol-Lowering Therapy with Evolocumab in Patients with Familial Hypercholesterolemia/ Hypercholesterolemia in
Japan: Results of Post-Marketing Surveillance
Abstract #Mo3012, Poster Session, Zone 3, Science and Technology Hall, Level 2,
Monday, Nov. 13from 10:30-11:45 a.m. EST
- Intraindividual Variability in Serial Lipoprotein(a) Concentration Among Placebo-Treated Patients in the OCEAN(a)-DOSE Trial
Abstract #Sa1005, Poster Session, Zone 1, Science and Technology Hall, Level 2,
Saturday, Nov. 11from 11:30 a.m.-12:45 p.m. EST The Association of Lipoprotein(a) with Major Adverse Cardiovascular Events Among Individuals With and Without Baseline Atherosclerotic Cardiovascular Disease: The Mass General Brigham Lp(a) Registry
Abstract #MDP278, Moderated Digital Poster 4, Science and Technology Hall, Level 2,
Monday, Nov. 13from 12:10-12:15 p.m. EST
Investigator-Sponsored Studies (ISS)
- Stem Cell Factor Associated with Critical Limb Ischemia in Patients with Peripheral Artery Disease
Abstract #Su3229, Poster Session, Zone 3, Science and Technology Hall, Level 2,
Sunday, Nov. 12from 3:30-4:45 p.m. EST
- CAD Polygenic Risk Score and Incident Complex Coronary Revascularization in Adults with Atherosclerosis
Abstract #565, Poster Session, Zone 2, Science and Technology Hall, Level 2,
Monday, Nov. 13, 2023from 9:50-9:55 a.m. EST
Cardiovascular disease is a leading public health crisis in
For more information about LDL and to learn how to get a free LDL-C test*, visit WhatIsMyLDL.com.
*Terms and conditions apply. Programs subject to change; quantities may be limited.
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. Repatha has been studied for 12 years in 50 clinical trials with over 51,000 patients.
Repatha is approved in more than 75 countries, including the
Olpasiran (formerly known as AMG 890) is a small interfering RNA (siRNA) that targets lipoprotein(a), also known as Lp(a). We look forward to studying this treatment further in the Phase 3 clinical trial OCEAN(a)-Outcomes, which is currently recruiting.
Repatha® (evolocumab) Important U.S. Product Information
Repatha® is indicated:
- In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization
- As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)–lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL–C
- As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C
- As an adjunct to other LDL–C-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL–C
The safety and effectiveness of Repatha® have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hyperlipidemia.
IMPORTANT SAFETY INFORMATION
- Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.
- Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve.
- Adverse Reactions in Adults with Primary Hyperlipidemia: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).
- Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).
Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha® compared with 7.7% in patients that received placebo.
- Adverse Reactions in Pediatric Patients with HeFH: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, headache, oropharyngeal pain, influenza, and upper respiratory tract infection.
- Adverse Reactions in Adults and Pediatric Patients with HoFH: In a 12-week study in 49 patients, the adverse reactions that occurred in at least two patients treated with Repatha® and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis. In an open-label extension study in 106 patients, including 14 pediatric patients, no new adverse reactions were observed.
- Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.
Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436) or 844-REPATHA (844-737-2842) regarding Repatha® availability or find more information, including full Prescribing Information, at www.amgen.com and www.Repatha.com.
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 people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best Companies" by TIME.
This news release contains forward-looking statements that are based on the current expectations and beliefs of
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 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 for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, 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 at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
CONTACT: Amgen, Thousand Oaks
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