New Amgen Data To Be Presented At ESC Congress 2020 Highlighting Repatha® (evolocumab) Efficacy In High-Risk Patient Populations
THOUSAND OAKS, Calif., Aug. 25, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of 12 cardiovascular scientific research abstracts, including clinical trial and real-world evidence studies of Repatha® (evolocumab), that add to the growing body of evidence demonstrating the efficacy and safety of Repatha and the importance of managing high-risk patients in accordance with global treatment guidelines. The data will be presented at ESC Congress 2020 – The Digital Experience, organized by the European Society of Cardiology, Aug. 29–Sept. 1.
Notable abstracts include data from the first randomized controlled Phase 3 study of a PCSK9 inhibitor, Repatha, in pediatric patients with heterozygous familial hypercholesterolemia (HeFH), which will be presented as a late-breaking abstract in an oral presentation. HeFH is a genetic disorder that affects approximately 1 in 250 individuals globally and results in high levels of low-density lipoprotein cholesterol (LDL-C) at a very young age despite treatment with statins and other cholesterol-lowering therapies.1,2 With HeFH, there is an accelerated development and increased lifetime risk of atherosclerotic cardiovascular disease (ASCVD).3
A separate study across 18 European countries described how lipid-lowering therapy (LLT) is used for primary and secondary prevention of ASCVD and assessed how current practice impacts LDL-C goals recommended by the ESC/EAS guidelines. A third study across 10 European countries evaluated the reduction of LDL-C by the real-world use of Repatha in patients at very high-risk for a cardiovascular event and simulated the associated 10-year cardiovascular risk and risk reduction relative to baseline.
"The depth and breadth of data we are sharing with the scientific community reflects our commitment to developing and delivering transformative medicines that improve the lives of patients, including pediatric patients with genetically high LDL-C, who are at high lifetime risk for cardiovascular events," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are addressing the ongoing unmet need in LDL-C by understanding how Repatha may lower LDL-C in complex, high-risk populations who need more intensive lipid lowering therapies as an optimal treatment to achieve current clinical guidelines."
A list of Amgen-sponsored abstracts at ESC Congress 2020 can be found online and include:
Cardiovascular disease state and treatment studies
Cardiovascular disease cost burden on healthcare
There will also be an "Invited Talk" at the ESC/EAS Joint Session on DA VINCI Study: What have we learnt from 18 European countries on lipid management? on Sunday, Aug. 30 at 10:40 a.m. CEST.
About Amgen in the Cardiovascular Therapeutic Area
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 the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
About Repatha® (evolocumab)
Repatha is approved in more than 70 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.
Important EU Product Information
In Europe, Repatha is approved for use in:
Hypercholesterolaemia and mixed dyslipidaemia
Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non–familial) or mixed dyslipidaemia, as an adjunct to diet:
Homozygous familial hypercholesterolaemia
Established atherosclerotic cardiovascular disease
Primary hypercholesterolaemia and mixed dyslipidaemia in adults
Homozygous familial hypercholesterolaemia in adults and adolescents aged 12 years and over
Established atherosclerotic cardiovascular disease in adults
Important Safety Information
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Special Warnings and Precautions: Renal impairment: There is limited experience with Repatha in patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m2). Repatha should be used with caution in patients with severe renal impairment. Hepatic impairment: In patients with moderate hepatic impairment, a reduction in total evolocumab exposure was observed that may lead to a reduced effect on LDL-C reduction. Therefore, close monitoring may be warranted in these patients. Patients with severe hepatic impairment (Child-Pugh C) have not been studied. Repatha should be used with caution in patients with severe hepatic impairment. Dry natural rubber: The needle cover of the glass pre-filled syringe and of the pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions. Sodium content: Repatha contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially 'sodium-free'.
Interactions: No formal drug-drug interaction studies have been conducted for Repatha. No studies on pharmacokinetic and pharmacodynamics interaction between Repatha and lipid-lowering drugs other than statins and ezetimibe have been conducted.
Fertility, Pregnancy and Lactation: There are no or limited amount of data from the use of Repatha in pregnant women. Repatha should not be used during pregnancy unless the clinical condition of the woman requires treatment with evolocumab. It is unknown whether evolocumab is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. No data on the effect of evolocumab on human fertility are available.
Undesirable Effects: The following common (> 1/100 to < 1/10) adverse reactions have been reported in pivotal, controlled clinical studies: influenza, nasopharyngitis, upper respiratory tract infection, rash, nausea, back pain, arthralgia, injection site reactions. Please consult the SmPC for a full description of undesirable effects.
Pharmaceutical Precautions: Store in a refrigerator (2 degrees C – 8 degrees C). Do not freeze. Keep the pre-filled syringe or the pre-filled pen in the original carton in order to protect from light. If removed from the refrigerator, Repatha may be stored at room temperature (up to 25 degrees C) in the original carton and must be used within 1 month.
Important U.S. Product Information
Repatha is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor antibody indicated:
The safety and effectiveness of Repatha have not been established in pediatric patients with HoFH who are younger than 13 years old or 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. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha.
Allergic reactions: Hypersensitivity reactions (e.g. angioedema, 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 patients treated with Repatha and occurring 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.
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%).
The most common adverse reactions in the Cardiovascular Outcomes Trial (>5% of patients treated with Repatha and occurring 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 assigned to Repatha compared with 7.7% in those assigned to placebo.
Homozygous Familial Hypercholesterolemia (HoFH): 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.
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 www.Repatha.com.
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CONTACT: Amgen, Thousand Oaks
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