Repatha is an investigational 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.1 In Japan, LDL-C levels are not adequately controlled for many patients taking statins, nearly half of whom have not reached their LDL-C goal.2,3
"Submitting Repatha for marketing approval in
The Japanese New Drug Application for marketing approval for Repatha contains data from approximately 7,200 patients with high cholesterol in 11 Phase 3 trials, including Japanese patients from studies conducted in Japan. Overall, the Phase 3 studies 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), a rare and serious genetic disorder.4
In the U.S.,
High cholesterol is the most common form of dyslipidemia, which is an abnormality of cholesterol and/or fats in the blood.5,6 There are approximately 300 million cases of dyslipidemia in the U.S., Japan and
Familial hypercholesterolemia (FH) is an inherited condition caused by genetic mutations which lead to high levels of LDL-C at an early age,4 and it is estimated that less than one percent of people with FH (heterozygous and homozygous forms) in
About RepathaTM (evolocumab)
RepathaTM (evolocumab) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).1 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.14 Repatha, being developed by
The trademark Repatha has been filed and is registered in Japan. The FDA has provisionally approved the trade name Repatha.
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