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|Amgen Announces Positive Top-Line Results From Phase 3 GLAGOV Imaging Study Of Repatha® (Evolocumab)|
Detailed results from the Phase 3 GLAGOV trial will be presented during the upcoming
"We are pleased with the positive results of this landmark study showing that Repatha modifies the underlying process of atherosclerosis," said
GLAGOV is a Phase 3, multicenter, double-blind, randomized, placebo-controlled trial evaluating the impact of Repatha, a PCSK9 inhibitor, on coronary atheroma volume in 968 patients with CAD receiving optimized statin therapy and undergoing coronary catheterization. Patients were randomized to receive either monthly Repatha 420 mg or placebo subcutaneous injections.
No new safety concerns were identified in the GLAGOV trial. The incidence of treatment-emergent adverse events was comparable among both groups.
Harper continued, "Atherosclerosis is the major underlying cause of cardiovascular disease, which remains the leading cause of death worldwide. Now one year after the
Cardiovascular disease is the leading cause of death worldwide.1 In the U.S., there are approximately 11 million people with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) who have uncontrolled levels of low-density lipoprotein (LDL-C) over 70 mg/dL, despite treatment with statins or other cholesterol-lowering therapies.2,3 More than 60 percent of high-risk patients in Europe are still unable to adequately lower their LDL-C levels with statins or other currently approved lipid-lowering agents.4 Among very high-risk patients, the percentage is increased to more than 80 percent.4 It is estimated that less than one percent of people with FH (heterozygous and homozygous forms) in most countries are diagnosed.5
GLAGOV Study Design
Secondary endpoints included PAV regression (any reduction from baseline); change in total atheroma volume (TAV) from baseline to week 78; and regression (any reduction from baseline) in TAV.
About Repatha® (evolocumab)
The FOURIER outcomes trial is designed to evaluate whether treatment with Repatha or placebo on top of optimized statin therapy, reduces the risk of cardiovascular events in patients with clinically evident atherosclerotic disease. The trial completed patient enrollment in
Repatha is approved in more than 40 countries, including the U.S.,
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 U.S. 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 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 Amgen Cardiovascular
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The scientific information discussed in this news release relating to new indications is preliminary and investigative and is not part of the labeling approved by the
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