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Amgen seeks Japanese approval for Repatha to treat high cholesterol

Amgen has submitted a new drug application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking marketing approval for its Repatha (evolocumab), an investigational fully human monoclonal antibody, to treat high cholesterol, a most common form of dyslipidemia.

In Japan, Repatha is being developed by Amgen Astellas BioPharma, a joint venture between Amgen and Astellas Pharma, a Japanese pharmaceutical firm.

Repatha 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.

Amgen Research and Development executive vice-president Sean Harper said: "Submitting Repatha for marketing approval in Japan is an important milestone in our strategic partnership alliance with Astellas Pharma as we look forward to accomplishing our common goal of addressing the critical needs of patients with high cholesterol.

"We look forward to working with regulatory authorities in Japan to provide a new treatment option for patients whose cholesterol is uncontrolled with currently available therapies."

The NDA was based on data from about 7,200 patients with high cholesterol in 11 Phase III trials, including Japanese patients from studies conducted in Japan.

These Phase III trials evaluated the safety and efficacy of Repatha in patients with elevated cholesterol on statins with or without other lipid-lowering therapies; patients who cannot tolerate statins; patients with heterozygous familial hypercholesterolemia (HeFH); and patients with homozygous familial hypercholesterolemia (HoFH).

In August 2014, Amgen submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for Repatha to treat high cholesterol.

Amgen submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) in September 2014 through the centralized procedure for Repatha for the treatment of high cholesterol.