Study Met Primary Endpoint (Change From Baseline in LDL-C) and All Secondary Endpoints Repatha is the First PCSK9 Inhibitor to Demonstrate LDL-C Lowering Results in People Living with HIV [28-March-2020] THOUSAND OAKS, Calif. , March 28, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive results from the Evolocuma B E ffect on LDL-C Lower I
| THOUSAND OAKS, Calif., March 28, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive results from the EvolocumaB Effect on LDL-C LowerIng in SubJEcts with Human Immunodeficiency ViRus and INcreased Cardiovascular RisK (BEIJERINCK) study evaluating the efficacy and safety of Repatha® (evolocumab) in patients who are human immunodeficiency virus-positive (HIV+) and have high low-density lipoprotein cholesterol (LDL-C) despite stable background lipid-lowering therapy.1 The study demonstrated that treatment with Repatha significantly reduced LDL-C. The results were featured as an oral presentation during the virtual American College of Cardiology’s 69th Annual Scientific Session from March 28-30, 2020 with publication in the Journal of the American College of Cardiology (JACC) on March 30, 2020. “Certain antiretroviral treatments for HIV can increase LDL-C and change the lipid makeup of people living with HIV. This study increases our overall evidence base for Repatha, but also provides us with a better understanding of cholesterol management for this under-represented patient population,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “These positive results show that Repatha can help these patients lower their LDL-C, one of the most important modifiable risk factors for cardiovascular disease.” Results from the double-blind 24-week study show that in people living with HIV (PLHIV) with hypercholesterolemia or mixed dyslipidemia, monthly treatment with Repatha reduced LDL-C by 56.9% from baseline compared to placebo, meeting its primary endpoint.1 Patients treated with Repatha also demonstrated improved secondary outcomes versus placebo with 71.9% of patients achieving an LDL-C reduction of more than or equal to 50% from baseline and 65.4% of patients achieving an LDL-C of less than 70 mg/dL.1 No new safety concerns were identified in the BEIJERINCK trial.1 The subject incidence of treatment-emergent adverse events was comparable among both groups.1 “Professional guidelines, including most recently those from the European Society of Cardiology and the European Atherosclerosis Society, have called for greater research into the efficacy and safety of PCSK9 inhibitors in specific populations, like people living with HIV. The American Heart Association and American College of Cardiology multi-society cholesterol guidelines also identify HIV infection as a cardiovascular risk-enhancing factor,” said Professor Franck Boccara, M.D., PhD, cardiologist and primary study investigator, Sorbonne Université, Paris. “This is the first Phase 3 study to demonstrate that a PCSK9 inhibitor can effectively and safely reduce LDL-C in people living with HIV at risk for cardiovascular disease who have high cholesterol level despite statin treatment. Addressing uncontrolled LDL-C in this high-risk patient population is critical to maintain the progress that has been achieved in improving the lives of people living with HIV.” Approximately 38 million individuals live with HIV worldwide, with 1.1 million in the United States.2,3 Cardiovascular (CV) risk is estimated to be nearly double in PLHIV compared to individuals who don’t have HIV, and PLHIV face significant health challenges at earlier ages than people who don’t have HIV.4 The global burden of HIV-associated cardiovascular disease has tripled over the past two decades, and it will continue to increase as the population of individuals living with HIV ages.5 Today, 75 percent of PLHIV are over age 45.6 The Phase 3b BEIJERINCK study is part of Amgen’s PROFICIO (Program to Reduce LDL-C and cardiovascular Outcomes Following Inhibition of PCSK9 In different pOpulations) program of clinical and real-world evidence (RWE) studies investigating the impact of Repatha and examining the use of lipid-lowering therapies across different patient populations. To date, the PROFICIO program consists of 35 clinical trials including more than 41,000 patients worldwide and more than 80 real-world evidence studies. About BEIJERINCK Study Design 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 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. About Amgen in the Cardiovascular Therapeutic Area About Amgen 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. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. Forward-Looking Statements No forward-looking statement can be guaranteed and actual results may differ materially from those we project. 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SOURCE Amgen | ||
Company Codes: NASDAQ-NMS:AMGN |
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