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Repatha™ (Evolocumab) Data Analysis Examines Effect of Dosing on LDL-C Reduction and Duration of Response
THOUSAND OAKS, Calif. (Nov. 2, 2015) – Amgen (NASDAQ:AMGN) today announced that it will present 14 abstracts at the American Heart Association (AHA) Scientific Sessions 2015, from Nov. 7–11 in Orlando, Fla. New data analyses evaluating RepathaTM (evolocumab), an injectable proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor approved for certain patients with high low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol1 will be presented at the meeting.
“We look forward to sharing data at AHA that continue to add to our clinical understanding of the products in our cardiovascular portfolio,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Repatha and Corlanor, which were approved in the U.S. earlier this year, are testaments to our ongoing commitment to improving care for patients with cardiovascular disease.”
Repatha, approved by the U.S. Food and Drug Administration (FDA) on Aug. 27, is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C. The effect of Repatha on cardiovascular morbidity and mortality has not been determined.
In addition to Repatha clinical trial analyses, data from Amgen’s Center for Observational Research will be presented, including a poster and oral presentation on findings from the REGARDS (REasons for Geographic And Racial Differences in Stroke) study, and an oral presentation on the benefits of initiating beta blocker treatment in heart failure patients within seven days following hospital discharge. A global health economics study on the association between achievement of LDL-C reduction targets and cardiovascular disease risk among patients with familial hypercholesterolemia will also be presented.
Data to be presented at AHA Scientific Sessions 2015 include:
Center for Observational Research Presentations
Global Health Economics Presentations
About RepathaTM (evolocumab)
RepathaTM (evolocumab) 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
Important U.S. Product Information
RepathaTM is indicated as an adjunct to diet and:
The effect of RepathaTM on cardiovascular morbidity and mortality has not been determined.
The safety and effectiveness of RepathaTM have not been established in pediatric patients with HoFH who are younger than 13 years old.
The safety and effectiveness of RepathaTM have not been established in pediatric patients with primary hyperlipidemia or HeFH.
Important 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 (> 5% of Repatha™-treated patients and more common than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
In a 52-week trial, adverse reactions led to discontinuation of treatment in 2.2% of Repatha™-treated patients and 1% of placebo-treated patients. The most common adverse reaction that led to Repatha™ treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for Repatha™ and placebo, respectively).
Adverse reactions from a pool of the 52-week trial and seven 12-week trials:
Local injection site reactions that 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. The proportions of patients who discontinued treatment due to local injection site reactions in Repatha™-treated patients and placebo-treated patients were 0.1% and 0%, respectively.
Allergic reactions occurred in 5.1% and 4.7% of Repatha™-treated and placebo-treated patients, respectively. The most common allergic 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%).
Neurocognitive events were reported in less than or equal to 0.2% in Repatha™-treated and placebo-treated patients.
In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a total of 1,988 patients treated with Repatha™ had at least one LDL-C value < 25 mg/dL. Changes to background lipid-altering therapy were not made in response to low LDL-C values, and Repatha™ dosing was not modified or interrupted on this basis. Although adverse consequences of very low LDL-C were not identified in these trials, the long-term effects of very low levels of LDL-C induced by Repatha™ are unknown.
Musculoskeletal adverse reactions were reported in 14.3% of Repatha™-treated patients and 12.8% of placebo-treated patients. The most common adverse reactions that occurred at a rate greater than placebo were back pain (3.2% versus 2.9% for Repatha™ and placebo, respectively), arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%).
Homozygous Familial Hypercholesterolemia (HoFH): In 49 patients with homozygous familial hypercholesterolemia studied in a 12-week, double-blind, randomized, placebo-controlled trial, 33 patients received 420 mg of Repatha™ subcutaneously once monthly. The adverse reactions that occurred in at least 2 (6.1%) Repatha™-treated patients and more frequently than in placebo-treated patients, included upper respiratory tract infection (9.1% versus 6.3%), influenza (9.1% versus 0%), gastroenteritis (6.1% versus 0%), and nasopharyngitis (6.1% versus 0%).
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 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
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.2 Amgen'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.
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 biologics manufacturing 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.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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