Amgen Announces Expanded Approval of Repatha® (Evolocumab) in China for Primary Hypercholesterolemia and Mixed Dyslipidemia

Shanghai, December 201911th/PRNewswire/ -- Amgen announced that, based on the approval results from the National Medical Products Administration, Repatha^®(Evolocumab Injection) was approved for broader indications on November 22, 2019, becoming the first PCSK9 inhibitor approved in China for adult patients with primary hypercholesterolemia (including heterozygous familial hypercholesterolemia) and mixed dyslipidemia.

Evolocumab is an innovative lipid-lowering agent that reduces low-density lipoprotein cholesterol (LDL-C) levels by inhibiting the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to low-density lipoprotein receptors (LDLR), thereby increasing the number of LDLRs available to clear LDL from the bloodstream. This approval further expands the indications for evolocumab, allowing it to be used as an adjunct to diet in adult patients with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia to lower LDL-C levels. It may be administered in combination with statins or with statins and other lipid-lowering therapies in patients who have not achieved LDL-C goals despite maximally tolerated statin therapy, or as monotherapy or in combination with other lipid-lowering therapies in patients who are intolerant to or have contraindications for statin therapy.^[1]。

In recent years, the burden of cardiovascular disease in China has been increasing day by day, becoming a major public health issue. The summary of the "China Cardiovascular Disease Report 2018" shows that the prevalence and mortality rates of cardiovascular diseases in our country are still on the rise. It is estimated that there are about 290 million people currently suffering from cardiovascular diseases in China, making it the leading cause of death among Chinese residents, accounting for more than 40% of all disease-related deaths.^[2]Elevated LDL-C is one of the most important modifiable risk factors for cardiovascular disease, and many patients face the risk of recurrent cardiovascular events due to ineffective management of LDL-C.^[3]。

Ms. Mei-Ling Ke, Vice President and General Manager of Amgen China, stated, “We are delighted that Amgen’s groundbreaking lipid-lowering therapy, evolocumab, has been approved in China for broader indications. This means that more Chinese patients can manage their levels of ‘bad’ cholesterol (i.e., LDL-C) through innovative approaches. As China’s population ages, chronic diseases, including cardiovascular conditions, are becoming increasingly prevalent. To alleviate the disease burden associated with demographic shifts and address urgent unmet health needs, Amgen is committed to bringing innovative products, highly aligned with the challenges of aging, to more Chinese patients in need. The recent approval of new indications for evolocumab underscores our determination and commitment to supporting healthy aging in China and promoting a transformation in the healthcare system from ‘treating disease’ to ‘predicting and preventing’ it.”

Previously, Repatha^®It was approved by the National Medical Products Administration on July 31, 2018, for the treatment of homozygous familial hypercholesterolemia in adults and adolescents aged 12 years or older; and on January 28, 2019, it was approved for use in adult patients with established atherosclerotic cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization.

Note:

^[1]Evolocumab Injection Package Insert
^[2] Hu Shengshou, et al. Summary of the Report on Cardiovascular Diseases in China 2018. Chinese Circulation Journal 3 (2019): 2. DOI:10.3969/j.issn.1000-3614.2019.03.001
^[3] Goldstein JL, et al. Arterioscler Thromb Vasc Biol. 2009;29(4):431-438.

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Important Product Information

Repatha^®(Evolocumab Injection) is approved in China for:

1.  Reducing the Risk of Cardiovascular Events:
To reduce the risk of myocardial infarction, stroke, and coronary revascularization in adult patients with established atherosclerotic cardiovascular disease, by:

2.  Primary hypercholesterolemia (including heterozygous familial hypercholesterolemia) and mixed dyslipidemia:
As an adjunct to diet, indicated for the treatment of adult patients with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia to reduce low-density lipoprotein cholesterol (LDL-C) levels; homozygous familial hypercholesterolemia:

3.  Homozygous Familial Hypercholesterolemia:
For homozygous familial hypercholesterolemia in adults or adolescents aged 12 years and older.

It can be used in combination with dietary therapy and other low-density lipoprotein cholesterol (LDL-C) lowering treatments (such as statins, ezetimibe, LDL apheresis) for patients with homozygous familial hypercholesterolemia (HoFH) who require further reduction of LDL-C.