Amgen fetes 1st anniversary of getting expanded indication for Repatha

Lee Han-soo  Published 2019.09.11  13:56  Updated 2019.09.11 13:56


Amgen Korea said that its cardio-vascular disease business unit has held an event on Monday, celebrating the first anniversary of receiving an expanded indication for Repatha, a hyperlipidemia treatment.

Amgen employees celebrate the first anniversary of receiving an expanded indication for Repatha, at the company headquarters in Gangnam-gu, Seoul, on Monday.

Repatha is the world’s first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor that reduces LDL cholesterol levels, which is a significant cause of cardiovascular disease, and prescribed in hospitals nationwide based on the broadest indication among similar treatments in Korea.

Employees and executives of Amgen Korea who attended the internal event shared information on the current recurrence of cardiovascular diseases and its socio-economic effect and looked at achievements made by Repatha over the past year after the Ministry of Food and Drug Safety expanded the indication for the drug, the company said in a press release.

“While ischemic heart disease, including myocardial infarction mortality, has decreased by an average of 52 percent in 35 OECD countries from 1990 to 2015, the mortality rate in Korea alone increased to 43 percent,” Amgen Korea General Manager Noh Sang-kyung said. “In the current situation where the management of heart disease mortality is essential, it is essential to prevent the recurrence of myocardial infarction.”

As LDL-C is a significant risk factor for recurrence of myocardial infarction along with diabetes and hypertension, the company will do its best to ensure that patients at risk of recurring myocardial infarction manage their LDL-C effectively with Repatha, Noh added.

Repatha has demonstrated its efficacy in preventing cardiovascular diseases in phase 3 clinical trial FOURIER, participated in by 27,563 patients, as the company confirmed that the drug had the shortest period recurrence rate of 2.2 years among lipid-lowering agents.

The stud not only verified Repatha’s applicability in reducing cardiovascular risk in a broad range of diseases, including patients with a high risk of recurrence due to old age, underlying conditions and smoking but also set the grounds for Repatha’s approval.

The company received approval for Repatha in Korea as a treatment for homozygous familial hypercholesterolemia (HoFH), an ultra-rare disease, in April 2017. The regulatory agency further approved Repatha to reduce the recurrence risk of ASCVD (myocardial infarction, stroke, and peripheral vascular disease) and as an indication for hypercholesterolemia in August 2018.

The drug also became the first PCSK9 inhibitor to get reimbursement in Korea as the Ministry of Health and Welfare granted insurance benefits for Repatha in HoFH patients on Aug. 1, 2018.

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