Amgen (NASDAQ:AMGN) has announced the availability of Repatha® (evolocumab), the first PCSK9 inhibitor for lowering high cholesterol, in Singapore.
Repatha® is a new class of drugs called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. It is a fully human monoclonal antibody that inhibits PCSK9 from binding to low-density lipoprotein (LDL) receptors.
How does Repatha® work?
Statin therapy has been the primary treatment for lowering high cholesterol. In addition to causing less cholesterol to be made, they increase the liver’s ability to break cholesterol down. Despite this, many patients are still unable to control their cholesterol levels and need better options. Repatha® works differently from statin therapy by binding to PCSK9, inhibiting it from binding to LDL receptors in the liver.
This absence of PCSK9 enables our bodies to have more LDL receptors that can remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood. LDL-C is known as “bad cholesterol” because it contributes to plaque buildup in arteries and is a key risk factor for heart disease.
Transforming the burden of Cardiovascular disease (CVD)
Elevated LDL-C is recognized as a major risk factor for cardiovascular disease (CVD). CVDs, such as heart disease and stroke, are Singapore’s leading cause of death, accounting for 1 in every 3 deaths in 2015.
4 CVDs also result in steep direct and indirect costs for patients. The average medical cost for an acute stroke is over S$22,000, which is the equivalent of almost two months of an average Singaporean family’s income.
“While available treatments for other diseases are advancing in leaps and bounds, there hasn’t been much movement to address high cholesterol since the development of statin therapy in the late 1980s,” said Dr. Peter Yan Chee Hong, Consultant Cardiologist at Gleneagles Medical Centre. “Repatha® provides a new treatment option for patients who experience side effects while on statin therapy or remain unable to control their cholesterol levels.”
The key strategy to prevent heart disease is to improve the management of dyslipidemia. Dyslipidemia is the elevation of plasma cholesterol, triglycerides (TGs), or both, or a low high-density lipoprotein level that contributes to the development of atherosclerosis.
High elevated LDL-C, is the most common form of dyslipidemia, which leads to abnormally high levels of cholesterol and/or fats in their blood. Management of abnormal LDL-C is both extremely important and challenging.
Data from clinical trials demonstrated that Repatha® resulted in up to 77% additional LDL-C reduction in patients receiving background statin therapy.
Approved by the Health Sciences Authority, the cholesterol-lowering drug Repatha® is indicated for:
1) The treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet:
- In combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
- Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
2) The treatment of adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia in combination with other lipid-lowering therapies.
“This is the first significant innovation in 30 years for cholesterol management, and we look forward to seeing how it will impact patient lives and help combat the rising burden of CVD,” said Raphael Ho, General Manager of Amgen Singapore. “Amgen has been growing its CVD research competency for more than a decade and we are committed to continue building a robust portfolio that addresses many of the unmet needs in high risk patients across Singapore.”