Combined Data From FOURIER and FOURIER-OLE Studies Show Earlier, Longer Use of Repatha Reduces Total CV Events
Analysis From Phase 2 OCEAN(a)-DOSE Study Shows Olpasiran Markedly Reduced Lp(a) Concentration Irrespective of Baseline Level
Amgen Convenes First LDL-C Action Summit to Help Improve State of Cardiovascular Disease Care in the U.S.
THOUSAND OAKS, Calif., March 1, 2023 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced new Repatha® (evolocumab) combined data from the Phase 3 FOURIER and FOURIER Open Label Extension (OLE) studies and the Phase 2 OCEAN(a)-DOSE study of investigational olpasiran, an siRNA that reduces lipoprotein(a) [Lp(a)] by more than 90%. Additional data from Amgen's Center for Observational Research and Amgen funded investigator studies, including YELLOW-III from Mount Sinai will be presented at the American College of Cardiology's 72nd Annual Scientific Session together with World Heart Federation's World Congress of Cardiology (ACC.23/WCC) in New Orleans, LA, March 4-6, 2023.
The Repatha data evaluated all primary endpoint events from the patients enrolled in the parent FOURIER study (n=27,564), with a median follow up of 2.2 years, and for patients who received Repatha during FOURIER-OLE (n=6,635), for an additional 3 years of follow up. These findings showed that over the duration of follow-up, patients with atherosclerotic cardiovascular disease (ASCVD) who were already receiving statin therapy had a reduction in adverse cardiovasclar outcomes with earlier initiation of Repatha. This was shown by the reduction in total cardiovascular (CV) endpoint events (cardiovascular disease, myocardial infarction, stroke, unstable angina or coronary revascularization) in patients that had initiated Repatha in the parent study and continued Repatha in the OLE, as compared to those who were in the standard of care group in the parent study and only initiated Repatha during the OLE.
"Amgen is at the forefront of lipid research and we are focused on addressing some of the most significant cardiovascular disease risk factors, including unmanaged LDL-C and Lp(a)," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "The robust body of evidence on Repatha continues to underscore its clinical importance as a transformative therapy in lowering LDL-C to reduce CV events like heart attack and stroke in patients with ASCVD. We are proud to provide Repatha to millions of patients worldwide at an affordable cost."
Olpasiran is an investigational siRNA-based therapy that has been shown to reduce Lp(a) by more than 90% in Phase 2. A new analysis of the OCEAN(a) Dose study will examine whether the percentage of Lp(a) reduction with olpasiran is affected by baseline Lp(a) concentrations. The results showed that olpasiran markedly reduced Lp(a) concentration irrespective of baseline level in those with ASCVD and Lp(a) >150 nmol/L. These findings provide important insights into how much Lp(a) reduction may be achieved with olpasiran in settings where the Lp(a) burden is very high.
While in New Orleans, Amgen will also convene the first ever LDL-C Action Summit to address the state of cardiovascular disease (CVD) care in the United States. This first meeting will bring together key CVD community stakeholders, including the American College of Cardiology, American Heart Association, Cardio Health Alliance, Baim Institute for Clinical Research and PERFUSE, Family Heart Foundation, National Forum and the National Lipid Association, to understand the challenges in the treatment landscape and discuss strategies and opportunities for collaboratively improving lipid management among the highest risk ASCVD patients.
"I look forward to presenting at this important summit convening multiple stakeholders across academia, societies, and industry to address the gaps in ASCVD care," said C. Michael Gibson, M.D., CEO of the non-profit Baim Institute of Clinical Research, and Professor of Medicine, Harvard. "Despite the clear benefits of LDL lowering, people at risk are not being identified, and when they are, they reach the guidelines goal only a third of the time. The implementation science needs to be stepped up to match the amazing basic/clinical science of lipid lowering. We need to work together to get this changed."
For more information on the Amgen abstracts, see below. To learn more about what Amgen is doing to address CVD, please visit Amgen.com and follow us on Twitter, LinkedIn, Instagram, TikTok and YouTube.
- Low-Density Lipoprotein Cholesterol Testing Following Myocardial Infarction Hospitalization Among Medicare Beneficiaries
Digital Presentation (#1135-005), Saturday, March 4
- Characteristics of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Monoclonal Antibody New Users and Changes in LDL-C Using Real-World Data: A U.S. Perspective
Moderated Poster Session (#1008-05), Saturday, March 4, 10:00-10:10am CST
- Reduction in Total Cardiovascular Events with the PCSK9 Inhibitor Evolocumab in Patients with Cardiovascular Disease in the Combined FOURIER and FOURIER Open-Label Extension (OLE) Studies
Moderated Poster (#1003-13), Theater, Saturday, March 4, 11:00-11:10am CST
- Use of Negative Control Outcomes to Assess the Comparability of PCSK9i mAb Treatment Protocols Following Myocardial Infarction
Flatboard Poster (#1347-138), Saturday, March 4, 1:45-2:30pm CST
- Association of Baseline Lipoprotein(a) and Percentage of Lipoprotein(a) Lowering with Olpasiran
Moderated Poster (#1027-05), Saturday, March 4, 3:15-3:25pm CST
Investigator Sponsored Studies (ISS)
- Effect of Evolocumab on Coronary Plaque Characteristics in Stable Coronary Artery Disease: A Multimodality Imaging Study (YELLOW-III)
Late-Breaker (#403-14), Saturday Mar 4, 12:45 pm - 12:55 pm
- Pragmatic Implementation Science to Assess Lipid Optimization in Peripheral Artery Disease: Primary Results of the OPTIMIZE PAD-1 Trial
Flatboard Poster (#1726-007) Monday Mar 6, 2023,10:45 am - 11:30 am
- Inhibition of PCSK9 with evolocumab modulates immune-cell activation in high-risk ASCVD patients – The Metchnikoff Clinical Trial
Moderated Poster (#1008-07), Saturday Mar 4, 2023, 10:15 am - 10:25 am
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 U.S., Japan, Canada and in all 28 countries that are members of the European Union. Applications in other countries are pending.
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 Phase 3 clinical trial, which is currently recruiting.
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 2022, Amgen was named one of the "World's Best Employers" by Forbes and one of "America's 100 Most Sustainable Companies" by Barron's.
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 Forward-Looking Statements
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CONTACT: Amgen, Thousand Oaks
Megan Fox, 805-447-1423 (media)
Jessica Akopyan, 805-440-5721 (media)
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