"We look forward to sharing data at AHA that continue to add to our clinical understanding of the products in our cardiovascular portfolio," said
Repatha, approved by the
Corlanor, approved by the
In addition to Repatha and Corlanor clinical trial analyses, data from
Data to be presented at AHA Scientific Sessions 2015 include:
Repatha
Clinical Presentation
Global Health Economics Presentations
Corlanor
Clinical Presentation
Global Health Economics Presentations
About Repatha™ (evolocumab)
Repatha™ (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
Repatha™ is indicated as an adjunct to diet and:
The effect of Repatha™ on cardiovascular morbidity and mortality has not been determined.
The safety and effectiveness of Repatha™ have not been established in pediatric patients with HoFH who are younger than 13 years old.
The safety and effectiveness of Repatha™ 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-
About Corlanor® (ivabradine)
Corlanor® (ivabradine) blocks the hyperpolarization-activated cyclic nucleotide-gated (HCN) channel responsible for the cardiac pacemaker, which regulates heart rate. Corlanor reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current ("funny" current) to slow the heart rate with no effect on ventricular repolarization and no effects on myocardial contractility.2 Corlanor was developed by Les Laboratoires Servier. Through a collaboration with Servier,
Important U.S. Product Information
Corlanor® is indicated to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction < 35%, who are in sinus rhythm with resting heart rate > 70 beats per minute (bpm) and either are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use.
Important Safety Information
Please contact Amgen Medinfo at 800-77-
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.3
About
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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