The First PCSK9 Inhibitor Approved in Hong Kong for the Lowering of High Cholesterol

HONG KONG, Dec. 6, 2016 /PRNewswire/ -- Amgen today announced the availability of the first PCSK9 inhibitor for high cholesterol in Hong Kong. Approved by the Hong Kong Department of Health, the cholesterol-lowering drug evolocumab is indicated for use as an adjunct to diet and statin therapy for the treatment of adults with familial hypercholesterolemia (FH) including heterozygous FH (HeFH) and homozygous FH (HoFH), or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C)¹.

Evolocumab is a 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.² _­  

In Hong Kong, CVD or heart disease is the third leading cause of death.³ Every year, heart disease accounts for 13.2% of all deaths.⁴ One strategy to prevent heart disease is to improve the management of dyslipidemia.⁵  High cholesterol, particularly elevated LDL-C, is the most common form of dyslipidemia, which is an abnormality of cholesterol and/or fats in the blood.^6,7 Elevated LDL-C is recognized as a major risk factor for CVD.^8,9

Management of abnormal LDL-C is a challenge.¹⁰ A Hong Kong study found 24% of patients do not achieve target levels of LDL-C (< 2.6 mmol/L) despite statin treatment.¹¹ Data from clinical trials demonstrated that evolocumab resulted in up to 77% additional LDL-C reduction in patients receiving background statin therapy, which is expected to reduce their risk of experiencing heart disease and a stroke.¹²

Amgen Cardiovascular

This new treatment option underlines the growing importance of utilizing human genetics to address diseases such as CVD and heart disease -- both of which have a large impact on our society as a whole, if left untreated.

"At Amgen, we believe in a 'biology first' approach through the use of cutting-edge science and technology to study the subtlest biological mechanisms in search of therapies that will improve the lives of those who suffer from diseases. With the introduction of evolocumab in Hong Kong,  we are excited that there is a new treatment option for patients who have elevated levels of cholesterol, despite using other lipid-lowering therapies," said Dr Victoria Elegant, Vice President Regional Medical for Amgen's Japan Asia Pacific region.

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.¹⁸

Amgen's research into cardiovascular disease, and potential treatment options, is part of a growing competency at Amgen that utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular 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 Familial hypercholesterolemia

Familial hypercholesterolemia (FH) is an inherited condition caused by genetic mutations which lead to high levels of LDL-C at an early age,¹³ and it is estimated that many people with FH (heterozygous and homozygous forms) are undiagnosed.¹⁴ 

Patients can have either one of two types of FH.¹³ Heterozygous FH is the more common type of FH and occurs in approximately one in 200 to 500 people.¹⁴ It can cause LDL-C levels twice as high as normal (e.g., >190 mg/dL or >4.9 mmol/L).¹⁵ Individuals with HeFH have one altered copy of a cholesterol-regulating gene.¹⁵ Homozygous FH is the rare, more severe form, occurring in approximately one in a million individuals.¹⁶ It can cause LDL-C levels more than six times as high as normal (e.g., 650-1,000 mg/dL or 16.8-25.9 mmol/L).¹⁴ An individual with HoFH has two altered copies of the same cholesterol-regulating genes (one from each parent).¹³

About evolocumab

Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).² 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.¹⁷ 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.²

Repatha^® (evolocumab) is a prescription only medicine in Hong Kong. Please read the full Prescribing Information prior to administration and full prescribing information is available upon request.

Media contact

Seok Lin Hong, Amgen at shong01@amgen.com, tel: (852)2843-1114

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 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 one of the world's leading independent biotechnology companies, 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.

Forward-Looking Statements

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