Full Press Release Details
THOUSAND OAKS, Calif. , Nov. 12, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced that it will present 13 abstracts at the upcoming American Heart Association (AHA) Scientific Sessions 2014 being held Nov. 15-19 in Chicago , including data from studies evaluating evolocumab, an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood. 1
"We will be sharing diverse data exploring the potential clinical utility of evolocumab at this year's AHA Scientific Sessions, including multiple new analyses that examine longer-term treatment with evolocumab, the effect on different lipid parameters and the efficacy of two dosing regimens," said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen. "The medical community is keenly aware of the significant unmet need for many patients with high cholesterol, and we are continuing to work with regulatory agencies on the global filing packages we have submitted, including in the U.S. and EU."
Several of the abstracts are from the large and comprehensive evolocumab clinical trial program, PROFICIO ( P rogram to R educe LDL-C and Cardiovascular O utcomes F ollowing I nhibition of P C SK9 I n Different P O pulations).
Data to be presented at the AHA Scientific Sessions 2014 include:
Clinical Development
Early Development
Sponsored Research
Observational Research
Health Economics
About Evolocumab Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). 1 PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood. 2 Evolocumab, being developed by Amgen scientists, is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood. 1
About PROFICIO: The Evolocumab Clinical Trial Program PROFICIO, which stands for the P rogram to R educe LDL-C and Cardiovascular O utcomes F ollowing I nhibition of P C SK9 I n Different P O pulations, is a large and comprehensive clinical trial program evaluating evolocumab in 22 clinical trials, with a combined planned enrollment of approximately 35,000 patients.
The Phase 3 program includes 16 trials to evaluate evolocumab administered every two weeks and monthly in multiple patient populations, including in combination with statins in patients with hyperlipidemia ( LAPLACE -2 and YUKAWA-2); in patients with hyperlipidemia who cannot tolerate statins (GAUSS-2 and GAUSS-3); as a stand-alone treatment in patients with hyperlipidemia (MENDEL-2); in patients whose elevated cholesterol is caused by genetic disorders called heterozygous (RUTHERFORD-2 and TAUSSIG) and homozygous (TESLA and TAUSSIG) familial hypercholesterolemia; the effects of evolocumab on lipoprotein metabolism (FLOREY); and the administration of evolocumab in statin-treated hyperlipidemic patients (THOMAS-1 and THOMAS-2).
Five ongoing studies in the evolocumab Phase 3 program will provide long-term safety and efficacy data. These include FOURIER ( F urther Cardiovascular OU tcomes R esearch with PCSK9 I nhibition in Subjects with E levated R isk), which will assess whether treatment with evolocumab in combination with statin therapy compared to placebo and statin therapy reduces recurrent cardiovascular events in approximately 27,500 patients with cardiovascular disease; EBBINGHAUS ( E valuating PCSK9 B inding Anti B ody I nfluence o N Co G nitive H e A lth in High Cardiovasc U lar Risk S ubjects), which will evaluate the effect of evolocumab on cognitive function in a subset of patients enrolled in FOURIER; OSLER-2 ( O pen Label S tudy of L ong T ER m Evaluation Against LDL-C Trial-2) in patients with high cholesterol who completed any of the Phase 3 studies; GLAGOV ( GL obal A ssessment of Plaque Re G ression with a PCSK9 Antib O dy as Measured by Intra V ascular Ultrasound), which will determine the effect of evolocumab on coronary atherosclerosis in approximately 950 patients undergoing cardiac catheterization; and TAUSSIG ( T rial A ssessing Long Term US e of PC S K9 I nhibition in Subjects with G enetic LDL Disorders), which will assess the long-term safety and efficacy of evolocumab on LDL-C in patients with severe familial hypercholesterolemia including patients with homozygous familial hypercholesterolemia. The DESCARTES ( D urable E ffect of PC S K9 Antibody C omp AR ed wi T h Plac E bo S tudy) study, a long-term safety and efficacy trial in patients with hyperlipidemia at risk for cardiovascular disease, has been completed, presented and published.
About Amgen's Commitment to Cardiovascular Disease Amgen is dedicated to addressing important scientific questions in order to advance care and improve the lives of patients with cardiovascular disease. Through its own research and development efforts and innovative partnerships, Amgen has built a robust cardiology pipeline consisting of several investigational molecules in an effort to address a number of today's important unmet patient needs, such as high cholesterol and heart failure.
About Amgen 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 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.
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CONTACT: Amgen, Thousand Oaks Kristen Davis : 805-447-3008 (media) Trish Hawkins : 805-447-5631 (media) Arvind Sood : 805-447-1060 (investors)
References 1. Amgen Data on File, Investigator Brochure. 2. Abifadel M, Varret M, Rabes JP, et al. Mutations in PCSK9 Cause Autosomal Dominant Hypercholesterolemia. Nat Genet . 2003;34:154-156.